BECKMAN COULTER, INC.

Entity profile compiled from public source records

Public Record Profile Registrations: 21 510(k) filings: 1 Recalls: 15

Known Identifiers & Locations

FEI Numbers 1000206808, 1017835, 2050010, 2050012, 2122870, 2919016, 3000203293, 3002721051, 3002807272, 3002807663, 3003244710, 3004198394, 3006543086, 3006677029, 3007448124, 3007750372, 3008244372, 3008629785, 3016954941, 3021394862, 3027977508
Owner Operator Numbers 2050012
Locations Covered ARRAS Pas-de-Calais, FR; BREA, CA, US; Baierbrunn Bavaria, DE; Bengaluru (Bangalore) Urban Karnataka, IN; CARLSBAD, CA, US; CHASKA, MN, US; HIALEAH, FL, US; Hebron, KY, US; INDIANAPOLIS, IN, US; Indianapolis, IN, US; Krefeld North Rhine-Westphalia, DE; MARSEILLE, CEDEX 9 Bouches-du-Rhone, FR; Miami, FL, US; Munchen Bavaria, DE; O CALLAGHANS MILLS Clare, IE; SUNTO-GUN Shizuoka, JP; Sunto-Gun Shizuoka, JP; Suzhou Jiangsu, CN; West Sacramento, CA, US; Woerden Utrecht, NL

Registered Establishments (21)

Registration # Establishment Name Location Establishment Type(s) Action
1017835 BECKMAN COULTER, INC. HIALEAH, FL, US Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
1061932 BECKMAN COULTER, INC. Miami, FL, US Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
2050010 BECKMAN COULTER, INC. CARLSBAD, CA, US Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
2050012 BECKMAN COULTER, INC. BREA, CA, US Develop Specifications But Do Not Manufacture At This Facility View Details
2122870 BECKMAN COULTER, INC. CHASKA, MN, US Manufacture Medical Device View Details
2919016 Beckman Coulter, Inc. West Sacramento, CA, US Manufacture Medical Device View Details
3002721051 Beckman Coulter GmbH Krefeld North Rhine-Westphalia, DE Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3003244710 Beckman Coulter Biotechnology (Suzhou) Co., Ltd Suzhou Jiangsu, CN Develop Specifications But Do Not Manufacture At This Facility View Details
3004198394 BECKMAN COULTER, INC. INDIANAPOLIS, IN, US Develop Specifications But Do Not Manufacture At This Facility View Details
3006543086 NORMAND-INFO S.A.S.U. ARRAS Pas-de-Calais, FR Manufacture Medical Device View Details
3006677029 Beckman Coulter Biomedical GmbH Munchen Bavaria, DE Develop Specifications But Do Not Manufacture At This Facility View Details
3007448124 Beckman Coulter, Inc Indianapolis, IN, US Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3007750372 Beckman Coulter Distribution B.V. Woerden Utrecht, NL Export Device to the United States But Perform No Other Operation on Device View Details
3008244372 Beckman Coulter K. K. Sunto-Gun Shizuoka, JP Develop Specifications But Do Not Manufacture At This Facility View Details
3008629785 Beckman Coulter, Inc. Hebron, KY, US Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3016954941 Beckman Coulter India Private Limited Bengaluru (Bangalore) Urban Karnataka, IN Manufacture Medical Device View Details
3021394862 Beckman Coulter Biomedical GmbH Baierbrunn Bavaria, DE Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3027977508 BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD. Suzhou Jiangsu, CN Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
8023018 Immunotech SAS, a Beckman Coulter company MARSEILLE, CEDEX 9 Bouches-du-Rhone, FR Develop Specifications But Do Not Manufacture At This Facility View Details
9612296 Beckman Coulter Mishima K.K. SUNTO-GUN Shizuoka, JP Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
9680746 Beckman Coulter Ireland Inc O CALLAGHANS MILLS Clare, IE Manufacture Medical Device View Details

510(k) Premarket Notifications (1)

Submission # Device Name Decision Date Decision Description Action
K032162 ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY 2003-08-08 Substantially Equivalent View Details

FDA Recall History (15)

Recall # Product Description Initiation Date Status Action
Z-0002-2008 FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use. Reason: Pressure (from recapped tubes) or vacuum (from under-filled short-draw tubes) will cause inaccurate results if not properly vented. 2007-02-22 Terminated View Details
Z-0002-2013 COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples. Reason: The recall was initiated because Beckman Coulter has confirmed that the Coulter PrepPlus may experience intermittant reagent level sense failures where the instrument may not produce a warning that a reagent vial is low or out of reagent. 2012-01-20 Terminated View Details
Z-0003-2013 IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with the IMMAGE Immunochemistry System. Reason: The recall was initiated because Beckman Coulter has confirmed customer reports of QC shifts, lot-to-lot variation, and an increase in the percent of patient samples recovering >20 IU/mL using the Lots# M012376 and M101865 of IMMAGE RF reagent. The lots identified for the RF reagent might produce false abnormal results. 2012-01-27 Terminated View Details
Z-0009-06 Synchron LX Systems Version 4.5 Operating Software Reason: Synchron LX Systems Operating Software Version 4.5/v4.6 CBD (Chemistry Database) introduced an adjustment to the urine Uric Acid database calculation scheme which for some patients, depending on the volume of 24 hour urine sample, results may be reduced from above the upper limit of the laboratory's reference interval to below the limit. 2005-09-06 Terminated View Details
Z-0016-2013 Active Renin IRMA Kit, Part Number DSL25100 Product Usage: The Renin IRMA; DSL25100 immunoradiometric assay kit provides materials for the quantitative measurement of Renin in plasma. This assay is intended for in vitro diagnostic use. Reason: The recall was initiated because Beckman Coulter has confirmed that the Active Renin IRMA Test Kit may exhibit a decrease in stability of the coated tubes. As a result, quality control and patient sample results may be falsely elevated by up to 72%. 2012-01-20 Terminated View Details
Z-0021-2013 Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: " Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood. " Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF). Reason: Beckman Coulter is recalling the UniCel DxH 800 Coulter Cellular Analysis System because the NRBC, Differential or Reticulocyte mix chamber drain ports may become plugged by rubber pieces from specimen tube caps, and result in biohazard or chemical exposure and/or the potential for generating incorrect results. 2012-04-03 Terminated View Details
Z-0025-2025 Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids. Reason: When the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is configured to automatically request a calibration order, the instrument can process the order with expired calibrator material. If the calibration curve is generated with an expired calibration material lot, this may lead to a hazardous situation of erroneously high or low patient results reported to the physicians. 2024-04-18 Open, Classified View Details
Z-0028-2012 Coulter PrepPlus 2, Part Number: 378600, Serial Numbers: 1001008698, 1001008699, and 10018700. Coulter PrePlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples. Reason: The recall was initiated because Beckman Coulter has confirmed an issue with the Coulter PrePlus 2. The reagent level sensing is impaired and will give no warning when a reagent vial is low or out of reagent. Due to the size difference in the vertical mounts, the reagent rack is not aligned optimally for the probe to aspirate or level sense the antibody. This misalignment yields impaired reagen 2010-08-12 Terminated View Details
Z-0032-2022 Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK Reason: Through customer feedback, testing a sample with cardiac troponin I concentration that are >270,000 pg/mL may cause carryover into the hsTnl reagent pack. The carryover is caused by sample-to-pack carryover predominantly into the particle well of the reagent pack by way of the probe. The particle well then becomes contaminated by the high sample from the probe. The extent of the carryover is dependent on sample concentration and frequency of high concentration samples. 2021-08-09 Open, Classified View Details
Z-0032-2026 DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i Clinical Analyzer Reason: On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC tests, CC sample status will remain In Progress with no errors, may cause processing delays. 2025-08-04 Open, Classified View Details
Z-0033-2013 CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5. Reason: The recall was initiated because Beckman Coulter has determined that the specimen and prepared sample stability claims stated in the product labeling for tetraCXP software and CYTO-STAT reagents (CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5) need to be updated for alignment with current standards and clinical decision-making associated with lymphocyte immunophenotyping 2012-05-22 Terminated View Details
Z-0034-2013 CYTO-STAT tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number 6607073. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5. Reason: The recall was initiated because Beckman Coulter has determined that the specimen and prepared sample stability claims stated in the product labeling for tetraCXP software and CYTO-STAT reagents (CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5) need to be updated for alignment with current standards and clinical decision-making associated with lymphocyte immunophenotyping 2012-05-22 Terminated View Details
Z-0035-2013 TetraCXP Software System, Part Number A40051. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5. Reason: The recall was initiated because Beckman Coulter has determined that the specimen and prepared sample stability claims stated in the product labeling for tetraCXP software and CYTO-STAT reagents (CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5) need to be updated for alignment with current standards and clinical decision-making associated with lymphocyte immunophenotyping 2012-05-22 Terminated View Details
Z-0039-04 Coulter AcT 5diff Open Vial Hematology Analyzers Part Numbers: 6605580, 6605581, 6605604 Reason: Samples with high fat content will not count platelets accurately. 2003-09-08 Terminated View Details
Z-0040-04 Coulter AcT 5diff Cap Pierce Hematology Analyzers Part Numbers: 6605641, 6605705 Reason: Samples with high fat content will not count platelets accurately. 2003-09-08 Terminated View Details

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