FDA Device Recall Z-0024-2015: Siemens Healthcare Diagnostics, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0024-2015.

Recall Res Number

Z-0024-2015

Recalling Firm / Manufacturer

Siemens Healthcare Diagnostics, Inc.

FEI Number

2517506

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2014-08-28

Date Posted

2014-10-06

Date Terminated

2015-03-30

Product Code

JIT

Event Number

69149

Product Quantity

6562

Product Description 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 for Recall 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

Action Details An Urgent Medical Device Recall notice, dated August 2014, was provided to all Dimension Vista MMB CAL customers who received the affected lots to notify them of the issue, the potential risk to health, and actions to be taken by customers. Customers were instructed to discard lots 3JD045, 4BD064, 4CD012, and 4DD065, and recalibrate with lot 4FD073.

Distribution Pattern Worldwided distribution: US (nationwide) and countries of: Australia, Austria, Belgium, Canada, Denmark, Germany, Finland, France, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, Slovenia, South Korea, Spain, and Switzerland.

Code Information / Serial Numbers lot 3JD045, exp. 2014-10-01; lot 4BD064, exp. 2015-02-01; lot 4CD012, exp. 2015-03-01; and lot 4DD065, exp. 2015-05-01.

Related Establishments / Registrations

NITTOBO MEDICAL CO., LTD. MEDICAL DEVELOPMENT CENTER Registration: 1000403749 View Registration
SCIENTIFIC SUPPLIES & TECHNOLOGY, INC. Registration: 1036362 View Registration
MERCEDES MEDICAL LLC Registration: 1063851 View Registration
HEMAGEN DIAGNOSTICS, INC. Registration: 1181055 View Registration
Fisher Diagnostics Registration: 1181121 View Registration
WATERS CORPORATION Registration: 1218959 View Registration
NOVA BIOMEDICAL CORPORATION Registration: 1219029 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 1219913 View Registration
MEDICA CORP. Registration: 1220972 View Registration
ALDEN MEDICAL LLC Registration: 1221361 View Registration
VERICHEM LABORATORIES, INC. Registration: 1221645 View Registration
CURRIER PLASTICS Registration: 1319436 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 1319681 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 1319808 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 1319809 View Registration
ABBOTT LABORATORIES Registration: 1415939 View Registration
STANBIO LABORATORY Registration: 1616487 View Registration
Fujirebio Diagnostics, Inc. Registration: 1643621 View Registration
HORIBA INSTRUMENTS INCORPORATED Registration: 1827821 View Registration
ARKRAY FACTORY USA, INC. Registration: 1832816 View Registration
Biomerica Registration: 2025099 View Registration
INOVA DIAGNOSTICS, INC. Registration: 2026994 View Registration
Diagnostic Automation/ Cortez Diagnostics Inc,. Registration: 2029372 View Registration
Carolina Liquid Chemistries Corp. Registration: 2030861 View Registration
QUALIGEN, INC. Registration: 2032087 View Registration
Diazyme Laboratories, Inc. Registration: 2032900 View Registration
BECKMAN COULTER, INC. Registration: 2050010 View Registration
BECKMAN COULTER, INC. Registration: 2050012 View Registration
KAMIYA BIOMEDICAL COMPANY LLC Registration: 2084025 View Registration
CLINIQA CORPORATION Registration: 2085064 View Registration
BECKMAN COULTER, INC. Registration: 2122870 View Registration
FUJIFILM Healthcare Manufacturing Corporation Minamiashigara Takematsu Office Registration: 2155 View Registration
DIASORIN INC. Registration: 2182595 View Registration
DIAGNOSTICA STAGO, INC. Registration: 2245451 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 2250051 View Registration
INSTRUMENTATION LABORATORY CO. Registration: 2431530 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration
POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC. Registration: 2435505 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS INC. Registration: 2517506 View Registration
Fujirebio Diagnostics, Inc. Registration: 2521625 View Registration
Bio-Rad Laboratories, Inc. Registration: 2915274 View Registration
HORIBA ABX SAS Registration: 3000148879 View Registration
Ortho-Clinical Diagnostics European Support Center Registration: 3000308930 View Registration
Siemens Healthcare Diagnostics Inc Registration: 3002637618 View Registration
Ortho Clinical Diagnostics Registration: 3002642396 View Registration
Canon Medical Diagnostics Corporation Fuji Plant. Registration: 3002694097 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED Registration: 3002806944 View Registration
ABBOTT GmbH Registration: 3002809144 View Registration
Fujirebio Inc. Registration: 3002895169 View Registration
DIAMOND DIAGNOSTICS Inc Registration: 3003030793 View Registration
FUJIFILM Wako Pure Chemical Corporation Diagnostics Design Office (Amagasaki) Registration: 3003419906 View Registration
ARKRAY Factory, Inc. Registration: 3003422726 View Registration
Agilent Technologies Singapore (International) Pte Ltd. Registration: 3003423869 View Registration
Nagase Diagnostics Co., Ltd. Registration: 3003460426 View Registration
FUJIFILM Healthcare Manufacturing Corporation MIE Office Registration: 3003522182 View Registration
SEKISUI MEDICAL CO., LTD. Tsukuba Plant Registration: 3003539867 View Registration
Tecan Trading AG Registration: 3003559191 View Registration
B.R.A.H.M.S GmbH Registration: 3003561301 View Registration
Infrared Laboratory Systems dba SYNERMED Registration: 3003593973 View Registration
DENKA CO., LTD. Registration: 3003871639 View Registration
CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH Registration: 3003951180 View Registration
CANTERBURY SCIENTIFIC LTD. Registration: 3003982601 View Registration
SHIMA LABORATORIES CO., LTD. Registration: 3003985394 View Registration
SENSOR HEALTH PRODUCTS, INC. Registration: 3004192065 View Registration
HYPHEN BIOMED SASU Registration: 3004434070 View Registration
RANDOX LABORATORIES LIMITED Registration: 3004493545 View Registration
SCITECK Diagnostics Registration: 3004875840 View Registration
ABBOTT IRELAND DIAGNOSTICS DIVISION Registration: 3005094123 View Registration
ABBOTT LABORATORIES Registration: 3005333358 View Registration
TOSOH BIOSCIENCE, INC. Registration: 3005529799 View Registration
OTSUKA ELECTRONICS CO., LTD. Registration: 3005622096 View Registration
FUJIFILM Healthcare Americas Corporation Registration: 3005625991 View Registration
CEZANNE SAS Registration: 3005847079 View Registration
Diamond Diagnostics Inc. Registration: 3006198300 View Registration
Ortho-Clinical Diagnostics Registration: 3007111389 View Registration
EUROIMMUN US INC. Registration: 3007118747 View Registration
VitalScientific Registration: 3007662974 View Registration
ABBOTT IRELAND Registration: 3008344661 View Registration
Agilent Technologies Inc. Registration: 3009189893 View Registration
7051395 CANADA INC DBA HTA DIRECT SOURCING Registration: 3009518015 View Registration
Sysmex America, Inc. Registration: 3009711478 View Registration
SYSMEX CORPORATION Registration: 3010421384 View Registration
Microgenics Corporation Registration: 3010939897 View Registration
EXACT DIAGNOSTICS Registration: 3011926203 View Registration
DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI Registration: 3011989923 View Registration
SHINO-TEST CORPORATION Registration: 3012240236 View Registration
5-DIAGNOSTICS Registration: 3012289015 View Registration
INSTRUMENTATION LABORATORY SPA Registration: 3012348571 View Registration
THE BINDING SITE Registration: 3012471076 View Registration
Ortho Clinical Diagnostics, K.K. Registration: 3012963943 View Registration
ATSI Logistics Center ApS Registration: 3013059683 View Registration
High Technology, Inc. Registration: 3013660430 View Registration
MKA MEDIKAL IC VE DIS TICARET SANAYI LIMITED SIRKETI Registration: 3014279513 View Registration
PHC Corporation Registration: 3014353045 View Registration
RANDOX LABORATORIES LIMITED Registration: 3014607865 View Registration
Fujirebio Inc. Ube Facility Registration: 3014643041 View Registration
ABBOTT LABORATORIES Registration: 3016438761 View Registration
BIALEX LAB Registration: 3021841051 View Registration
BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD. Registration: 3027977508 View Registration
PHC Corporation Registration: 3029973107 View Registration
BIO-RAD LABORATORIES, INC. Registration: 3032705 View Registration
SUPPLY MAX NY INC Registration: 3033967997 View Registration
INSTRUMENTATION LABORATORY CO. - Devens Registration: 3037000637 View Registration
Sekisui Diagnostics P.E.I. Inc. Registration: 8020316 View Registration
Siemens Healthcare Diagnostics Manufacturing Ltd. Registration: 8020888 View Registration
IMMUNODIAGNOSTIC SYSTEMS LTD. Registration: 8021924 View Registration
Immunotech SAS, a Beckman Coulter company Registration: 8023018 View Registration
TOSOH CORP. Registration: 8031673 View Registration
AXIS-SHIELD DIAGNOSTICS, LTD. Registration: 8032314 View Registration
Nagase Diagnostics Co., Ltd, Diagnostics Division, Ohito Diagnostics Plant Registration: 8043889 View Registration
WALLAC OY Registration: 8043909 View Registration
Agilent Technologies Denmark ApS Registration: 9610099 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610126 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610529 View Registration
BIOKIT S.A. Registration: 9610746 View Registration
Siemens Healthcare Diagnostics Products GmbH Registration: 9610806 View Registration
NIPRO CORPORATION ODATE FACTORY Registration: 9610987 View Registration
ARKRAY, INC. Registration: 9611444 View Registration
TOSOH AIA, INC. Registration: 9612316 View Registration
SYSMEX CORPORATION TECHNO PARK Registration: 9613959 View Registration
The Binding Site Group Ltd. Registration: 9614373 View Registration
WATERS TECHNOLOGIES IRELAND, LTD. Registration: 9616673 View Registration
Beckman Coulter Ireland Inc Registration: 9680746 View Registration
TRINITY BIOTECH, PLC Registration: 9681576 View Registration
SENTINEL CH. SPA Registration: 9681753 View Registration
IBL INTERNATIONAL GMBH Registration: 9710337 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Medical Device Recall: Z-0024-2015

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer