| Z-0017-2014 |
Dimension Vista (R) Urinary/Cerebrospinal Fluid Protein (UCFP) Flex (R) Reagent Cartridge Lot 11349BB
The Urinary / Cerebrospinal Fluid Protein method is an in vitro diagnostic test for the quantitive measurement of protein in urine and cerebrospinal fluid on the Dimension Vista System.
Reason: Siemens has confirmed an increase on absorbance errors when calibrating Dimension Vista Urinary/Cerebrospinal Fluid Protein (U CFP) Flex Reagent Cartridge lot 11349 BB.
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2012-12-19 |
Terminated
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View Details
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| Z-0024-2015 |
Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.
Reason: Siemens Healthcare Diagnostics has determined that Dimension Vista® Mass CKMB Isoenzyme Calibrator (MMB CAL) shows drift during routine stability monitoring that exceeds our acceptance criteria for drift over the shelf life of this product. Siemens has observed drift from 3% to 12% at MMB concentrations across the assay range. Depending on quality control limits, this drift may not have been d
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2014-08-28 |
Terminated
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View Details
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| Z-0030-2013 |
Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL)
Product Usage: Enzyme n Immunoassay, Phenobarbital
Reason: Firm has confirmed highter imprecision with the recalled lots on Beckman Coulter AU(R) Systems. Also, if the Syva(R) Emit(R) 2000 Phenobartbital Assay (4D019UL) lots D4, D5, D6, and/or D7 as an application on AU(R) Systems is used, the issue may be experienced. Firm has found that within-run imprecison of the recalled lots when run on an AU(R) System may be higher that what would normally be obs
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2012-07-30 |
Terminated
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View Details
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| Z-0031-2012 |
Dimension Vista(R) Cuvettes
The Dimension Vista(R) Cuvettes are for use on the Dimension Vista(R) System. The Dimension Vista(R) integrated system is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid. Vista (TM) system chemical and immunochemical applications utilize photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion selective multisensor technology for clinical use.
Reason: Siemens Healthcare Diagnostics has confirmed a low frequency defect in the molding of the Cuvettes that may result in Cuvette Ring and Cuvette Loader jams. It
has been determined that the issue is related to a molding defect with the Cuvette flange or "wing" breaking, resulting in an error condition. Therefore, patient results are not impacted.
|
2011-08-08 |
Terminated
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View Details
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| Z-0038-2012 |
Dimension(R) EXL LOCI Cardiac Troponin I Calibrator (RC621)
The LOCI Cardiac TNI Calibrator is an in vitro diagnostic product for the calibration on Cardiac Troponin I method on the Dimension(R) EXL (TM) Integrated chemistry system with LOCI(R) module.
Reason: Internal testing has confirmed that recovery of levels 2 and 3 of LOCl Cardiac Troponin I Calibrator is lower than expected bottle value. Following calibration with LOCl Cardiac Troponin I Calibrator, lot 1AD045 an upward shift in patient and QC results may be observed.
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2011-08-31 |
Terminated
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View Details
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| Z-0039-2017 |
Dimension Vista Calcium (CA) Flex reagent cartridge
Device Listing No.: D011443
Batch Number: 16060BB
Reason: Siemens Healthcare Diagnostics determined that the Dimension Vista Calcium (CA) Flex reagent cartridge lot # 16060BB may produce erroneously low or high results from specific well sets.
|
2016-08-03 |
Terminated
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View Details
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| Z-0052-2021 |
Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the
quantitative measurement of cardiac troponin I in human plasma Catalog Number: RF627, SMN# 10471068
Reason: Positive bias across the Analytical Measurement Range of the TNIH assay compared to an unaffected control lot. The average bias observed for
patient samples using lots EB0255 and EA0178 of the Dimension EXL Troponin compared with a control lot was +25%. A maximum bias of +34% in patient samples around the 99th percentile observed
|
2020-08-19 |
Terminated
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View Details
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| Z-0069-2012 |
Siemens Healthcare Diagnostics, Inc. Dimension(R) EXL Cardiac Troponin I Flex(R) Reagent Cartridges
Reason: Firm has confirmed customer complaints for low recovery of QC and patient samples.
|
2011-08-31 |
Terminated
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View Details
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| Z-0072-2017 |
ADVIA Centaur XPT Immunoassay System
Reason: The ADVIA Centaur XPT default setting for the Daily Maintenance Task (Daily Cleaning Procedure) frequency may have the Daily Maintenance Task frequency set to, As needed instead of Daily. Not performing the daily maintenance may impact any assay and can be detected through monitoring of quality control and calibration results. Systems running in a language other than English are not impacted.
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2016-04-28 |
Terminated
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View Details
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| Z-0081-2015 |
External power supply adaptors that accompany Clinitek Status+
The Clinitek Status systems is a urine analyzer.
Reason: The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User.
|
2014-09-19 |
Terminated
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View Details
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| Z-0081-2017 |
SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material Number (SMN) 10381282 (OUS), Unique Device Identification Number (UDI) 00630414964577; IVD ---
For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2000 XPi Systems Analyzers-for the qualitative detection of IgM antibodies to Rubella virus in human serum or plasma (EDTA and heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age.
Reason: Siemens received multiple customer complaints indicating an increase in false positive and indeterminate patient sample results and increased imprecision for several lots of Rubella IgM assay on the IMMMULITE 2000/IMMULITE 2000 XPi platforms.
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2016-08-24 |
Terminated
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View Details
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| Z-0082-2015 |
External power supply adaptors that accompany Clinitek Status Connect System
The Clinitek Status system is a urine analyzer.
Reason: The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User.
|
2014-09-19 |
Terminated
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View Details
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| Z-0082-2017 |
SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for US: L2KRM2(D), Siemens Material Number (SMN) for US: 10374021, REF/Catalog # for OUS: L2KRM2, SMN for OUS: 10381327; Unique Device Identification Number (UDI) 00630414961996; IVD ---
For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2000 XPi Systems Analyzers-for the qualitative detection of IgM antibodies to Rubella virus in human serum or plasma (EDTA and heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age
Reason: Siemens received multiple customer complaints indicating an increase in false positive and indeterminate patient sample results and increased imprecision for several lots of Rubella IgM assay on the IMMMULITE 2000/IMMULITE 2000 XPi platforms.
|
2016-08-24 |
Terminated
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View Details
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| Z-0083-2015 |
External power supply adaptors that accompany Clinitek Status Power Supply Adaptor - Spare Part
The Clinitek Status system is a urine analyzer.
Reason: The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User.
|
2014-09-19 |
Terminated
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View Details
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| Z-0089-2023 |
Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD
Siemens Material Number (SMN): 10464340
Catalog Number: K3048A
Reason: Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Potential for Erroneous Result. If an HDLC QC or patient result is obtained without an Abnormal Reaction [E145]: flag, a falsely depressed or elevated result ranging from -90% to 133% may be observed.
|
2022-08-24 |
Open, Classified
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View Details
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| Z-0093-2023 |
N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD
Siemens Material Number (SMN): 10446297
Reason: N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF).
|
2022-08-30 |
Open, Classified
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View Details
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| Z-0094-2023 |
N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD
Siemens Material Number (SMN): 10446299
Reason: N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF).
|
2022-08-30 |
Open, Classified
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View Details
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| Z-0101-2021 |
ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems
Siemens Material Number (SMN): 10361941
Reason: Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a potential adjustment of hyperglycemic therapy. Positively biased fructosamine results may prompt changes in glucose management that may affect glycemia. In extreme situations, more aggressive management of glycemia may occur and contribute to hypoglycemia.
|
2020-09-22 |
Open, Classified
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View Details
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| Z-0102-2014 |
Siemens RAPIDPoint 400 system blood gas analyzer
Product Usage:
These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: RAPIDPoint 400 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, Hct RAPIDPoint 405 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili
Reason: RAPIDPoint 400 Series, RAPIDPoint 500, or
RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample
|
2012-09-17 |
Terminated
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View Details
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| Z-0102-2015 |
Siemens ADVIA Centaur Systems HBc Total (HBcT), Reagent. For In Vitro Diagnostic Use
Catalog Number: 07566733
Siemens Material Number: 10309508
The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDTA, or lithium or sodium heparinized) using the ADVIA Centaur and ADVIA Centaur XP system.
Reason: Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results.
|
2014-09-15 |
Terminated
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View Details
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| Z-0102-2021 |
Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems
Siemens Material Number (SMN): 11097637
Reason: Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a potential adjustment of hyperglycemic therapy. Positively biased fructosamine results may prompt changes in glucose management that may affect glycemia. In extreme situations, more aggressive management of glycemia may occur and contribute to hypoglycemia.
|
2020-09-22 |
Open, Classified
|
View Details
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| Z-0103-2014 |
Siemens RAPIDPoint 405 system blood gas analyzer
Product PUsage:
These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: RAPIDPoint 400 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, Hct RAPIDPoint 405 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili
Reason: RAPIDPoint 400 Series, RAPIDPoint 500, or
RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample
|
2012-09-17 |
Terminated
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View Details
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| Z-0103-2015 |
ADVIA Centaur Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use.
Catalog Number: 07566733
Siemens Material Number: 10309508
The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDT A, or lithium or sodium heparinized) using the ADVIA Centaur CP system.
Reason: Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results.
|
2014-09-15 |
Terminated
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View Details
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| Z-0104-2014 |
Siemens RAPIDPoint 500 system blood gas analyzer
Product Usage:
RAPIDPoint 500 System: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili
Reason: RAPIDPoint 400 Series, RAPIDPoint 500, or
RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample
|
2012-09-17 |
Terminated
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View Details
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| Z-0104-2023 |
Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay
Reason: Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the worst case, there is a potential for erroneously elevated lithium patient results, which may lead to inappropriate dosage adjustment, potentially affecting treatment efficacy.
|
2022-09-19 |
Open, Classified
|
View Details
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| Z-0105-2014 |
Siemens RAPIDLab 1240 system blood gas analyzer
Product Usage:
RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb
Reason: RAPIDPoint 400 Series, RAPIDPoint 500, or
RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample
|
2012-09-17 |
Terminated
|
View Details
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| Z-0105-2023 |
Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
Reason: Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the worst case, there is a potential for erroneously elevated lithium patient results, which may lead to inappropriate dosage adjustment, potentially affecting treatment efficacy.
|
2022-09-19 |
Open, Classified
|
View Details
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| Z-0106-2014 |
Siemens RAPIDLab 1245 system blood gas analyzer
Product Usage:
RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb
Reason: RAPIDPoint 400 Series, RAPIDPoint 500, or
RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample
|
2012-09-17 |
Terminated
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View Details
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| Z-0107-2014 |
Siemens RAPIDLab 1260 system blood gas analyzer
Product Usage:
RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb
Reason: RAPIDPoint 400 Series, RAPIDPoint 500, or
RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample
|
2012-09-17 |
Terminated
|
View Details
|
| Z-0108-2014 |
Siemens RAPIDLab 1265 system blood gas analyzer
Product Usage:
RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb
Reason: RAPIDPoint 400 Series, RAPIDPoint 500, or
RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample
|
2012-09-17 |
Terminated
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View Details
|
| Z-0113-2019 |
ADVIA Centaur CKMB Calibrator, Cat No. 09318028
Product Usage:
For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
Reason: A potential bias was identified with certain kits compared to the internal standards.
|
2018-07-24 |
Terminated
|
View Details
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| Z-0114-2019 |
ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748
Product Usage:
For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
Reason: A potential bias was identified with certain kits compared to the internal standards.
|
2018-07-24 |
Terminated
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View Details
|
| Z-0115-2019 |
ADVIA Centaur CKMB Master Curve Material, Cat No. 07867768
Product Usage:
For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
Reason: A potential bias was identified with certain kits compared to the internal standards.
|
2018-07-24 |
Terminated
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View Details
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| Z-0115-2021 |
Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes:
(01)00630414599151(10)98034139(17)20210130 and (01)00630414599151(10)32478139(17)20210130
Atellica IM HER-2/neu (H2n) calibrator, 2 Pack, Catalog No. SMN 10995592, UDI Code
(01)00630414599168(10)22695A49(17)20201211
ADVIA Centaur HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10308994, UDI codes :
(01)00630414471235(10)43157138(17)20210130
(01)00630414471235(10)81653138(17)20210130
(01)00630414471235(10)99728138(17)20210130
(01)00630414471235(10)24043138(17)20210130
(01)00630414471235(10)32477138(17)20210130
Advia Centaur Systems HER-2/neu (H2n) calibrator, 2 Pack, Catalog No. SMN 10308993, UDI Codes:
(01)00630414471228(10)64661A48(17)20201112
(01)00630414471228(10)81211A48(17)20201112
(01)00630414471228(10)91743A48(17)20201112
(01)00630414471228(10)22124A49(17)20201211
Product Usage: This product is intended to be used for in vitro diagnostic use in calibrating the ADVIA Centaur systems HER-2/neu assay.
Reason: Siemens confirmed that the Upper Limit of Normal (ULN) as claimed in the Instructions for Use (IFU) was no longer achieved. This can potentially result in false positive or false negative results.
|
2020-08-25 |
Terminated
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View Details
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| Z-0116-2019 |
Atellica IM CKMB Calibrator, Cat No. 10995532
Product Usage:
For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
Reason: A potential bias was identified with certain kits compared to the internal standards.
|
2018-07-24 |
Terminated
|
View Details
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| Z-0117-2019 |
Atellica IM CKMB Master Curve Material, Cat No. 10995534
Product Usage:
For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
Reason: A potential bias was identified with certain kits compared to the internal standards.
|
2018-07-24 |
Terminated
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View Details
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| Z-0121-2011 |
EasyLink Informatics Systems QCFIRST Custom Rule
The EasyLink Informatics System is classified as a data calculator and processing module for use with In-vitro diagnostic devices. The EasyLink is included with the Dimension Vista System (K051087), and may be used with other Siemens analyzers, as a communications and connectivity workstation for integration with laboratory information system (LIS) networks.
Reason: the EasyLink QCFIRST custom rule does not operate as intended.
|
2010-07-23 |
Terminated
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View Details
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| Z-0124-2022 |
Atellica IM 1300 Analyzer, SMN 11066001
Reason: Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result, customers at these altitudes may observe an increased number of Reagent Volume Check Errors.
|
2021-09-28 |
Open, Classified
|
View Details
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| Z-0125-2022 |
Atellica IM 1600 Analyzer, SMN 11066000
Reason: Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result, customers at these altitudes may observe an increased number of Reagent Volume Check Errors.
|
2021-09-28 |
Open, Classified
|
View Details
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| Z-0127-2015 |
Dimension Vista HbA1c
Reason: In March, Siemens Healthcare Diagnostics issued an Urgent Medical Device Correction for decreased recovery of patient samples with the Dimension Vista® CSA & CSAE Flex® reagent cartridges when whole blood samples are run from Small Sample Containers (SSC). Siemens has confirmed that when whole blood samples are run from SSC, HbA1c values may exhibit a percent bias ranging from - 8.2% t
|
2014-08-14 |
Terminated
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View Details
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| Z-0128-2015 |
ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic)
Catalog Number:
03439230 (2 pack)
Reason: Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system
|
2012-10-09 |
Terminated
|
View Details
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| Z-0129-2015 |
ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic)
Catalog Number: 06567787 (6 pack)
Reason: Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system
|
2012-10-09 |
Terminated
|
View Details
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| Z-0130-2015 |
ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic)
Catalog Number: 672182005 (US Reference 6 pack)
Reason: Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system
|
2012-10-09 |
Terminated
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View Details
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| Z-0134-2021 |
Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma
Catalog Number: K2115, SMN# 10642444
Reason: Low outlier resultsgenerated with Alkaline Phosphatase (ALPI) Flex reagent cartridge.The maximum difference observed with a patient sample was approximately -27% at a concentration of 129 U/L (2.15 ukat/L). The low outlier results are generated from the last five (5) tests of the well
|
2020-08-25 |
Terminated
|
View Details
|
| Z-0139-2011 |
Dimension Vista V-LYTE Standard A, Catalog No K820
For the calibration of Na+/K+/Cl- on the Dimension vista System.
Reason: High potassium content in the affected lots results in the potential for low potassium recovery for Dilution Check, QC and patient samples when run on the Dimension Vista System.
|
2010-08-19 |
Terminated
|
View Details
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| Z-0148-2015 |
siemens Dimension Phenytoin Flex Reagent Cartridge
The PTN method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended to measure phenytoin (dilantin, diphenylhydantoin), an anti-epileptic drug, in human serum and plasma. PTN test results are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to ensure appropriate therapy.
Reason: Internal testing has confirmed a low absorbance range between the levels 1 and 5 calibrators with this lot resulting in the potential for a positive or negative bias and imprecision across the PTN assay range.
|
2014-09-24 |
Terminated
|
View Details
|
| Z-0148-2020 |
Siemens Atellica CH 930 Analyzer.
Siemens Material Number (SMN): 11067000
Product Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical specimens
Reason: Atellica CH 930 Analyzer - Erroneous Indices for Hemolysis and Lipemia in Software versions 1.19.2 and below
|
2019-07-30 |
Terminated
|
View Details
|
| Z-0162-2013 |
Siemens ADVIA Centaur BR Assay: Catalog Number:
US: REF 02419937 (10214722) (50 Tests);
REF 03896216(10334837)(250 Tests) Not
CE Marked; OUS:
REF03204829(10310271)(50 Tests); REF
01157807(1 0314722) (250 Tests) CE
Marked; REF 09010686 (10340081)(250 Tests).
The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur and ADVIA Centaur XP systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage Ill breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.
Reason: BR Assay for CA 27.29 Calibration Interval Change due quality control (QC) results outside of the expected ranges.
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2012-09-11 |
Terminated
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| Z-0164-2015 |
Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)
Reason: Positive bias for Calibrator E lot kits ending in 38 and 39 with the ADVIA Centaur Systems Cortisol and Progesterone assays compared to the respective master curves.
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2014-09-26 |
Terminated
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| Z-0170-2015 |
Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117.
MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.
Reason: An increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Combo Panel Type 1 used with MicroScan Microbiology Systems.
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2014-10-17 |
Terminated
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