Roche Diagnostics Operations, Inc.
Indianapolis, IN
This page shows every FDA and USDA recall linked to Roche Diagnostics Operations, Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
151
Total Recalls
0013
First Recall
2026
Most Recent
cobas pro integrated solutions with cobas c 503 analytical units:
cobas pro sample supply unit, material numb...
Feb 27, 2026
· Device
Active
cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitr...
Nov 19, 2024
· Device
Active
Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative...
Sep 20, 2024
· Device
Active
Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (...
Nov 20, 2023
· Device
Active
cobas infinity central lab, Material Number 07154003001
Jan 12, 2023
· Device
Active
cobas e801 Immunoassay Analyzer
Jul 14, 2022
· Device
Active
Cobas u 601 urinalysis test system, Catalog number 06334601001
The cobas U 601 urinalysis test system is comp...
Oct 18, 2021
· Device
Terminated
cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
Jun 24, 2021
· Device
Terminated
IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro t...
Apr 26, 2021
· Device
Active
9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of sodium, potassium, chlor...
Feb 8, 2021
· Device
Terminated
CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking ant...
Jan 7, 2021
· Device
Terminated
CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin ti...
Jan 7, 2021
· Device
Terminated
A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and...
Dec 17, 2020
· Device
Terminated
Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and...
Dec 8, 2020
· Device
Active
Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units) Chemistry...
Dec 8, 2020
· Device
Active
cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
Nov 23, 2020
· Device
Terminated
Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quantitative det...
Nov 6, 2020
· Device
Terminated
cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended...
Oct 9, 2020
· Device
Terminated
DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only)
Material Number: 05987750001
Aug 31, 2020
· Device
Active
BenchMark ULTRA Advanced Staining System (IVD)-
Material Number: 05342716001
Aug 31, 2020
· Device
Active
Tina-quant Complement C4 ver.2, Catalog 05991994190
Aug 27, 2020
· Device
Terminated
Albumin Gen.2, Catalog 05166861190
Aug 27, 2020
· Device
Terminated
Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190
Aug 20, 2020
· Device
Terminated
Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and manage...
Mar 5, 2020
· Device
Terminated
cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical...
Jan 7, 2020
· Device
Terminated
Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti...
Oct 28, 2019
· Device
Terminated
Roche Diagnostics cobas Integra Albumin Gen.2
Catalog Number: 05166861190 - Product Usage: In vitro test for t...
Oct 16, 2019
· Device
Terminated
Cobas c Bilirubin Total Gen.3
Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative...
Oct 16, 2019
· Device
Terminated
Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical Use...
Oct 8, 2019
· Device
Terminated
Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum and...
Oct 4, 2019
· Device
Terminated
cobas c 701 and 702 Analyzer/Module-RF interference claims for the sTfR assay
Catalog Number: 05950821190
Aug 28, 2019
· Device
Terminated
cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference claims for the sTfR a...
Aug 28, 2019
· Device
Terminated
Roche Elecsys Anti-CCP Immunoassay
Catalog # 07251670190
Aug 23, 2019
· Device
Terminated
Roche Elecsys Anti-CCP Immunoassay
Catalog # 05031656160
Aug 23, 2019
· Device
Terminated
AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Ser...
Aug 13, 2019
· Device
Terminated
Online TDM Vancomycin Gen.3 ( 200 tests)
Catalog # 06779344190
Analyzer/Module: cobas c 311 and cobas c 501/50...
Jul 23, 2019
· Device
Terminated
Online TDM Vancomycin Gen.3 (100 tests)
Catalog # 06779336190
Analyzer/Module: cobas c 311 and cobas c 501/502
Jul 23, 2019
· Device
Terminated
cobas c513 Analyzer
Jul 18, 2019
· Device
Terminated
cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001
Jul 18, 2019
· Device
Terminated
Cobas 8000 Modular Analyzer Series:
cobas 8000 ISE module part Numbers : 05964075001
cobas c 701 module part...
Jul 18, 2019
· Device
Terminated
The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay for the quantitative in vitro de...
Jul 2, 2019
· Device
Terminated
Tina-Quant (Latex) HS Test System
(C-Reactive Protein (Latex) High Sensitive)
The Tina-Quant CRP (Latex) High...
Jan 24, 2017
· Device
Terminated
Cobas b 123 POC system
The cobas b 123 POC system is a fully automated POC system for whole blood in vitro mea...
Jan 23, 2017
· Device
Terminated
COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test
Catalog number 04528123160
Nov 11, 2016
· Device
Terminated
Tina-Quant Hemoglobin A1c Gen. 2
Hemoglobin A1c test
Catalog number 04528123190 / 05401640190
Nov 11, 2016
· Device
Terminated
Roche COBAS INTEGRA c111
Analyzer, Chemistry (Photometric, Discrete), for clinical use
Product Usage:
The Roc...
Nov 10, 2016
· Device
Terminated
MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the
Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6 system
The...
Oct 31, 2016
· Device
Terminated