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Roche Diagnostics Operations, Inc. Recalls

80 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Roche Diagnostics Operations, Inc..

80Total Recalls
1Critical
2.3MUnits Affected
Jan 20, 2026Most Recent
All Recalls

Every Roche Diagnostics Operations, Inc. Recall

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

80 recalls
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001 cobas pro...
Diagnostic Devices·1,261 affected·Jan 20, 2026
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocyst...
Diagnostic Devices·458 affected·Oct 17, 2024
High RiskFDA
Roche Diagnostics Operations, Inc.
Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; I...
Diagnostic Devices·5,263 affected·Oct 3, 2023
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas infinity central lab, Material Number 07154003001
Medical Devices·224 affected·Dec 12, 2022
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas e801 Immunoassay Analyzer
Diagnostic Devices·965 affected·Jul 14, 2022
High RiskFDA
Roche Diagnostics Operations, Inc.
Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 601 urinalysis test system is comprised of the cobas u 601 ur...
Diabetes Devices·636 affected·Oct 18, 2021
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
Medical Devices·2,058 affected·Jun 24, 2021
High RiskFDA
Roche Diagnostics Operations, Inc.
IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for the quantitative de...
Diagnostic Devices·20,468 affected·Apr 26, 2021
High RiskFDA
Roche Diagnostics Operations, Inc.
Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
Diagnostic Devices·10 affected·Apr 7, 2021
High RiskFDA
Roche Diagnostics Operations, Inc.
9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and li...
Diagnostic Devices·1,214 affected·Jan 6, 2021
High RiskFDA
Roche Diagnostics Operations, Inc.
CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications su...
Medical Devices·716,880 affected·Dec 2, 2020
High RiskFDA
Roche Diagnostics Operations, Inc.
CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin time testing for the monitori...
Medical Devices·212,093 affected·Dec 2, 2020
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
Medical Devices·152 affected·Nov 23, 2020
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be used for the configu...
Medical Devices·40 affected·Oct 9, 2020
CriticalFDA
Roche Diagnostics Operations, Inc.
DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001
Medical Devices·257 affected·Aug 31, 2020
RecallFDA
Roche Diagnostics Operations, Inc.
Albumin Gen.2, Catalog 05166861190
Medical Devices·11,963 affected·Aug 27, 2020
RecallFDA
Roche Diagnostics Operations, Inc.
Tina-quant Complement C4 ver.2, Catalog 05991994190
Medical Devices·180 affected·Aug 27, 2020
High RiskFDA
Roche Diagnostics Operations, Inc.
Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer
Diagnostic Devices·684 affected·Feb 7, 2020
High RiskFDA
Roche Diagnostics Operations, Inc.
Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum an...
Diagnostic Devices·712 affected·Oct 28, 2019
High RiskFDA
Roche Diagnostics Operations, Inc.
Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi co...
Diagnostic Devices·82 affected·Oct 4, 2019
RecallFDA
Roche Diagnostics Operations, Inc.
Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determinat...
Diagnostic Devices·7,032 affected·Sep 11, 2019
High RiskFDA
Roche Diagnostics Operations, Inc.
Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502
Medical Devices·27,676 affected·Jul 23, 2019
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001
Medical Devices·1 affected·Jul 18, 2019
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas c513 Analyzer
Medical Devices·2 affected·Jul 18, 2019
High RiskFDA
Roche Diagnostics Operations, Inc.
Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 module part Numbers : 05641489001 ...
Medical Devices·19 affected·Jul 18, 2019
High RiskFDA
Roche Diagnostics Operations, Inc.
Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160
Diagnostic Devices·550 affected·Jul 16, 2019
High RiskFDA
Roche Diagnostics Operations, Inc.
The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay for the quantitative in vitro determination of myoglobin in...
Diagnostic Devices·4,309 affected·Jul 2, 2019
High RiskFDA
Roche Diagnostics Operations, Inc.
MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6 system The Roche Diagnostics Omni S...
Diabetes Devices·97 affected·Oct 31, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test Catalog number 04528123160
Medical Devices·4,976 affected·Oct 4, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Product Usage: The Roche COBAS INTEGRA c111 a...
Diagnostic Devices·139 affected·Sep 27, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
Roche/Hitachi MODULAR Analytics Combination Systems Modular D/P: Clinical Chemistry Analyzer, Chemistry (Photometric, Discrete) for clin...
Diagnostic Devices·9,014 affected·Jul 15, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas p 471 centrifuge unit calculator/data processing module, for clinical use Product Usage: The cobas p312 pre-analytical system ...
Medical Devices·9,014 affected·Jul 15, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas p 701 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The URISYS 2400 Analyzer is a fu...
Diabetes Devices·9,014 affected·Jul 15, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
VS II Aliquoter System calculator/data processing module, for clinical use Product Usage: Elecysy 411 analyzer is a fully automated,...
Medical Devices·9,014 affected·Jul 15, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
URISYS 2400 Urine Analyzer Automated Urinalysis System Product Usage: The RSD 800 is a computer-controlled stand-alone sorting syste...
Medical Devices·9,014 affected·Jul 15, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
RSD 800 Sorting System calculator/data processing module, for clinical use Product Usage: The cobas 8000 Modular Analyze Series is a...
Medical Devices·9,014 affected·Jul 15, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas p 501 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The MODULAR PRE-ANALYTICS system...
Medical Devices·9,014 affected·Jul 15, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas p 512 Pre-Analytical Instrument calculator/data processing module, for clinical use Product Usage: The cobas 6800/8800 systems...
Diagnostic Devices·9,014 affected·Jul 15, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
ONLINE TDM Vancomycin 100 tests; ONLINE TDM Vancomycin 200 tests; Hitachi Vancomycin (Modular P); Hitachi Vancomycin (917, MOD P) The ...
Diagnostic Devices·53,897 affected·May 26, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
Estradiol II Elecsys and cobas e analyzers REF 03000079 190; M 6.5mL, R1 8 mL, R2 8 mL, IVD, For USA: CONTENT M Streptavidin-coated...
Diagnostic Devices·102,312 affected·Mar 7, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) The Tina-Quant CRP (Latex) High Sensitive Immunoturbidime...
Cardiac Devices·3,204 affected·Feb 26, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analy...
Medical Devices·35 affected·Feb 23, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
Accu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II Blood Glucose Monitoring System Accu-Chek inform II Blood Glucose Mon...
Diabetes Devices·5,604 affected·Feb 11, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gase...
Respiratory Devices·30 affected·Sep 3, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas b 123 Fluid Pack COOX REF 05170036001 400 Product Usage: The cobas b 123 POC system is a fully automated POC system for whole b...
Respiratory Devices·82 affected·Jul 14, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas b 123 Fluid Pack COOX REF 05169992001 200 Product Usage: The cobas b 123 POC system is a fully automated POC system for whole b...
Respiratory Devices·82 affected·Jul 14, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
S2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184 Blood Gas and Electrolytes Analyzer; The Roche Diagnostics Omni S ...
Diabetes Devices·19 affected·Jun 24, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
HDL-Cholesterol gen.3. For the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in serum and plasma.
Medical Devices·6,255 affected·May 7, 2015