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Roche Diagnostics Corporation Recalls

21 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Roche Diagnostics Corporation.

21Total Recalls
1Critical
1.2MUnits Affected
Jun 3, 2019Most Recent
All Recalls

Every Roche Diagnostics Corporation Recall

Sorted by most recent. Click any recall for full details.

21 recalls
High RiskFDA
Roche Diagnostics Corporation
The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in the sample to form an antigen/antibod...
Diagnostic Devices·8 affected·Jun 3, 2019
High RiskFDA
Roche Diagnostics Corporation
cobas e 801 immunoassay analyzer
Diagnostic Devices·149 affected·Mar 15, 2019
High RiskFDA
Roche Diagnostics Corporation
Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***added as of 5/10/19*** 03183700190 Product Usage: An In vit...
Diagnostic Devices·5,292 affected·Dec 17, 2018
High RiskFDA
Roche Diagnostics Corporation
COBAS INTEGRA 400 plus analyzer used in the following assays: a)Tina-quant Apolipoprotein A-1 ver.2 Catalog Number: 03032566122 b)Tin...
Diagnostic Devices·656 affected·Dec 14, 2018
High RiskFDA
Roche Diagnostics Corporation
cobas c 111 with ISE analyzers analyzer used in the following assays: a)Creatinine plus ver.2 Catalog Number: 05401470190; b)Trigly...
Diagnostic Devices·137 affected·Dec 14, 2018
High RiskFDA
Roche Diagnostics Corporation
Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001 Product Usage: The URISYS 1100 Urine Analyzer is a reflectance...
Diabetes Devices·14,398 affected·Sep 24, 2018
CriticalFDA
Roche Diagnostics Corporation
CoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160; CoaguChek XS PT Test 6 Strip...
Medical Devices·1,163,952 affected·Sep 13, 2018
High RiskFDA
Roche Diagnostics Corporation
Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical system is a computer controlled full...
Medical Devices·12 affected·Jul 16, 2018
High RiskFDA
Roche Diagnostics Corporation
cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for i...
Diagnostic Devices·35 affected·Apr 3, 2018
High RiskFDA
Roche Diagnostics Corporation
cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 3313522692 The Roche Diagnostics Omni S Analyzer is a fully automa...
Diabetes Devices·1,026 affected·Feb 22, 2018
High RiskFDA
Roche Diagnostics Corporation
cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer is a fully automa...
Diabetes Devices·1,026 affected·Feb 22, 2018
High RiskFDA
Roche Diagnostics Corporation
cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 3337154692 The Roche Diagnostics Omni S Analyzer is a fully autom...
Diabetes Devices·1,026 affected·Feb 22, 2018
High RiskFDA
Roche Diagnostics Corporation
Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 test
Diagnostic Devices·35,111 affected·Jan 2, 2018
High RiskFDA
Roche Diagnostics Corporation
Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3...
Diagnostic Devices·47 affected·Dec 22, 2017
High RiskFDA
Roche Diagnostics Corporation
Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
Medical Devices·399 affected·Jul 28, 2017
High RiskFDA
Roche Diagnostics Corporation
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix conf...
Medical Devices·3,433 affected·Jul 18, 2017
High RiskFDA
Roche Diagnostics Corporation
cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775279973 - cobas e 411 analyzer (disk system) and 04775201001/...
Diagnostic Devices·923 affected·Jul 5, 2017
High RiskFDA
Roche Diagnostics Corporation
Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elecsys 2010 analyzer ...
Diagnostic Devices·255 affected·Jul 5, 2017
High RiskFDA
Roche Diagnostics Corporation
Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311 analyzer cobas c 501/502 cob...
Diagnostic Devices·3,946 affected·Mar 21, 2017
High RiskFDA
Roche Diagnostics Corporation
Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx
Medical Devices·45 affected·Mar 1, 2017
High RiskFDA
Roche Diagnostics Corporation
cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for ana...
Medical Devices·5 affected·Dec 27, 2016