FDA Device Recalls

Recalls / Firms / Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc.

151 FDA device recalls on record.

DateClassProductReason
2026-01-20—cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, mat
2025-11-21—The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated m
2024-10-17—cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/70
2024-08-15—Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the qu
2023-10-03—Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001
2022-12-12—cobas infinity central lab, Material Number 07154003001
2022-07-14—cobas e801 Immunoassay Analyzer
2021-10-18—Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 601 urinalysis test syst
2021-06-24—cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
2021-04-26—IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage:
2021-04-07—Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the di
2021-04-07—Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnos
2021-01-06—9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of sodium, potass
2020-12-17—A calculator/data processing module for clinical use is an electronic device intended to store, retr
2020-12-08—Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 mod
2020-12-08—Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units)
2020-12-02—CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are
2020-12-02—CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prot
2020-11-23—cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinica
2020-11-06—Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quanti
2020-10-09—cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application i
2020-08-31—DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001
2020-08-31—BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001
2020-08-27—Tina-quant Complement C4 ver.2, Catalog 05991994190
2020-08-27—Albumin Gen.2, Catalog 05166861190
2020-08-20—Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190
2020-02-07—Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring
2020-01-07—cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for
2019-10-28—Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A v
2019-10-08—Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Cl
2019-10-04—Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human
2019-09-11—Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test for the qua
2019-09-11—Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro
2019-08-28—cobas c 701 and 702 Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 059508
2019-08-28—cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference claims for
2019-08-13—AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR An
2019-07-23—Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas
2019-07-23—Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Module: cobas c 311 and coba
2019-07-18—cobas c513 Analyzer
2019-07-18—Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 mo
2019-07-18—cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001
2019-07-16—Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190
2019-07-16—Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160
2019-07-02—The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay for the quantitative i
2016-10-31—MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6
2016-10-04—COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test Catalog number 04528123160
2016-10-04—Tina-Quant Hemoglobin A1c Gen. 2 Hemoglobin A1c test Catalog number 04528123190 / 05401640190
2016-09-27—Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Product Usag
2016-07-15—cobas p 312 Pre-Analytical System calculator/data processing module, for clinical use Product Usag
2016-07-15—cobas p 612 Pre-Analytical Instrument calculator/data processing module, for clinical use Product U
2016-07-15—Roche/Hitachi MODULAR Analytics Combination Systems Modular D/P: Clinical Chemistry Analyzer, Chemis
2016-07-15—Modular Pre Analytics ( EVO/Plus) Product Usage: The RSD 800A is a computer-controlled stand-online
2016-07-15—URISYS 2400 Urine Analyzer Automated Urinalysis System Product Usage: The RSD 800 is a computer-con
2016-07-15—cobas p 471 centrifuge unit calculator/data processing module, for clinical use Product Usage: The
2016-07-15—RSD 800 Sorting System calculator/data processing module, for clinical use Product Usage: The cobas
2016-07-15—RSD 800A Aliquoting System calculator/data processing module, for clinical use Product Usage: The R
2016-07-15—cobas p 701 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage:
2016-07-15—cobas 6000 Series system c6000, Chemistry (Photometric, Discrete), for clinical Use. Modular e601: I
2016-07-15—Roche COBAS INTEGRA 800 /800 CTS Analyzer Analyzer, Chemistry (Photometric, Discrete for Clinical us
2016-07-15—cobas e411 Immunoassay Analyzer e411: Immunoassay Analyzer Product Usage: The cobas p501/p701 instr
2016-07-15—cobas p 501 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage:
2016-07-15—cobas p 512 Pre-Analytical Instrument calculator/data processing module, for clinical use Product U
2016-07-15—VS II Aliquoter System calculator/data processing module, for clinical use Product Usage: Elecysy 4
2016-07-15—cobas 6800/8800 system Hepatitis Viral B DNA Detection Product Usage: The cobas p512 pre-analytical
2016-07-15—cobas 8000 Modular Analyzer Series c8000, Chemistry (Photometric, Discrete) for clinical use Modular
2016-05-26—ONLINE TDM Vancomycin 100 tests; ONLINE TDM Vancomycin 200 tests; Hitachi Vancomycin (Modular P); Hi
2016-03-07—Estradiol III; Elecsys and cobas e analyzers; REF 06656021 190; M 6.5 mL, R1 9 mL, R2 9 mL, For US
2016-03-07—Estradiol II Elecsys and cobas e analyzers REF 03000079 190; M 6.5mL, R1 8 mL, R2 8 mL, IVD, For
2016-02-26—Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) The Tina-Quant CRP (La
2016-02-23—cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoti
2016-02-11—Accu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II Blood Glucose Monitoring System A
2015-09-22—Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliq
2015-09-03—Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC system for whole blood in
2015-07-14—cobas b 123 Fluid Pack COOX REF 05169992001 200 Product Usage: The cobas b 123 POC system is a full
2015-07-14—cobas b 123 Fluid Pack COOX REF 05170036001 400 Product Usage: The cobas b 123 POC system is a full
2015-06-24—S2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184 Blood Gas and Electrolytes Anal
2015-05-07—Cholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vitro diagno
2015-05-07—LDL-Cholesterol gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the qua
2015-05-07—Uric Acid plus ver.2 In vitro test for the quantitative determination of uric acid in human serum,
2015-05-07—Creatinine Plus ver. 2. Intended for use on COBAS INTEGRA systems , cobas c111, and cobas c systems
2015-05-07—Cholesterol CHOD-PAP. In vitro diagnostic reagent system intended for use on the Hitachi systems fo
2015-05-07—Triglycerides/Glycerol Blanked. In vitro test for the quantitative determination of triglycerides i
2015-05-07—Triglycerides GPO. In vitro test for the quantitative determination of triglycerides in human serum
2015-05-07—Creatinine Plus. Intended for use on Hitachi/MODULAR systems for the quantitative determination of
2015-05-07—HDL-Cholesterol gen.3. For the quantitative determination of high-density lipoprotein Cholesterol (
2015-05-07—HDL-Cholesterol plus gen.3.; and Small Supersized Intended for use on COBAS Integra 800 and 400 plu
2015-05-07—LDL-Cholesterol plus gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for th
2015-05-07—Lactate. Intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas c111, Roche/Hitachi MODU
2015-03-23—Homocysteine test system - Homocysteine Reagent. 05385415190; Homocysteine 100 Tests, cobas c, COBAS
2014-12-18—Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
2014-11-20—ACCU-CHEK Tender I 13/80 10 pieces Product Usage: Intended for the infusion and/or injection of flu
2014-11-20—ACCU-CHEK Tender II 17/80 10 + 10 pieces Product Usage: Intended for the infusion and/or injection
2014-11-20—ACCU-CHEK Tender II 13/80 10 + 10 pieces Product Usage: Intended for the infusion and/or injection
2014-11-20—ACCU-CHEK Tender II 13/110 10 + 10 pieces Product Usage: Intended for the infusion and/or injection
2014-11-20—ACCU-CHEK Tender I 17/110 10 pieces Product Usage: Intended for the infusion and/or injection of fl
2014-11-20—ACCU-CHEK Tender II 17/60 10 + 10 pieces Product Usage: Intended for the infusion and/or injection
2014-11-20—ACCU-CHEK Tender I 17/60 10 pieces Product Usage: Intended for the infusion and/or injection of flu
2014-11-20—ACCU-CHEK Tender I 13/60 10 pieces Product Usage: Usage: Intended for the infusion and/or injectio
2014-11-20—ACCU-CHEK Tender I 13/110 10 pieces Product Usage: Intended for the infusion and/or injection of fl
2014-11-20—ACCU-CHEK Tender I 17/80 10 pieces Product Usage: Intended for the infusion and/or injection of flu
2014-11-20—ACCU-CHEK Tender II 17/110 10 + 10 pieces Product Usage: Intended for the infusion and/or injection
2014-11-20—ACCU-CHEK Tender II 13/60 10 + 10 pieces Product Usage: Intended for the infusion and/or injection
2014-09-25—ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System Product Usage:
2014-09-12—Omni Micro-electrode/reference electrode for cobas b221 analyzer. The Roche Diagnostics Omni S Anal
2014-07-31—Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve,
2014-05-21—cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773
2014-05-21—Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter
2014-05-21—cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 0314977
2014-04-14—ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Meters; 17 count sample stri
2014-03-13—Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analy
2014-02-28—Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number: 031118
2013-10-25—ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo System)\ The ACCU
2013-09-16—COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers 28122474001, 28122474692
2013-08-19—ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monit
2013-05-16—CoaguChek XS System (HCP) The CoaguChek XS System is intended for use by professional healthcare pr
2013-05-16—CoaguChek XS System (PST) The CoaguChek XS PT test strips are part of the CoaguChek XS System. The
2013-05-16—CoaguChek XS Plus System The CoaguChek XS Plus system for use by professional healthcare providers
2013-05-16—CoaguChek XS Pro System The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Tes
2013-04-25—B-CrossLaps/serum (B-CTx in serum) REF 11972308 160 100 tests Immunoassay for the in vitro quantit
2013-04-04—Cobas 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602
2013-03-06—ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Info
2013-03-06—CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the CoagCHEK XS Pro
2013-03-01—Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 05232732001. Use
2012-11-19—Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.
2012-11-14—Cobas b 123 POC system cobas b 123 POC system is fully automated POC system for whole blood in vitr
2012-11-01—Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a full
2012-03-12—ACCU-CHEK Aviva Nano Blood Glucose Meter No product labeling, beyond the labels applied to the met
2012-03-12—Elecsys Troponin I Immunoassay For the in-vitro quantitative determination of cardiac troponin I in
2012-03-12—Elecsys Troponin I STAT Immunoassay For the in-vitro quantitative determination of cardiac troponin
2012-01-31—Elecsys 2010 Analyzer Software version 06-07 The Elecsys 2010 analyzer is intended for the in vitro
2011-10-26—cobas c 311 Analyzer, Part Number: 04826876001 In-vitro diagnostic analyzer capable of performing c
2011-10-18—Roche Cobas c 111 Analyzer The Roche Cobas c 111 analyzer is an in-vitro diagnostic analyzer capable
2011-07-21—MagNA Pure LC 1.0 (software version 3.0.11). Roche Diagnostics Operations, Inc. An automated instru
2011-07-21—MagNA Pure LC 2.0 (software version 1.1.23 and 1.1.24) Roche Diagnostics Operations, Inc. An automa
2011-05-18—ACCU-CHECK PERFORMA STRIP NO. 05987288031, 100 BANDELETTES REACTIVES, ROCHE DIAGNOSTICS GMBH, WWW.AC
2010-12-07—Acetaminophen Test System for use on the Roche/Hitachi, part number 03255379190, Roche Diagnostics
2010-12-07—Acetaminophen Test System for use on the COBAS/INTEGRA/cobas c, part number 20767174322, Roche Dia
2010-10-26—MagNA Pure LC 2.0 Instrument, catalog number 05197686001, Roche Diagnostics, Indianapolis, IN Mag
2010-10-26—Factor II (prothrombin) G20210A kit, catalog number 03610195001, Roche Diagnostics, Indianapolis,
2010-10-26—Factor V Leiden kit catalog number 03610179001, Roche Diagnostics, Indianapolis, IN The Factor V
2010-10-11—Calcium Reagent, Calcium Test System for COBAS INTEGRA 400, 400 PLUS, 800, 800 CTS, cobas c 311,
2010-10-11—Calcium Reagent, Calcium Test System for cobas c 111, Part number 04718933190, Roche Diagnosti
2010-08-13—Cyclosporine Sample Pretreatment Reagent, COBAS INTEGRA, IVD, Roche Diagnostics GmbH, Assembled for
2010-02-05—ONLINE TDM N-acetylprocainamide, Part number 04642520190 N- acetylprocainamide reagent Roche Diagno
2009-10-07—Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 917 and Modular P; Catalog no. 0
2009-10-07—Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 911, 912, 917 and Modular P; Cat
2009-10-07—Roche/Hitachi GENT2 ONLINE TDM Gentamicin for Roche cobas c 501 analyzer systems; Catalog no. 04490
2009-07-22—Roche CoaguChek XS System, CoaguChek XS Plus Care Kit, Roche Diagnostics, Indianapolis, IN; Model Nu
2009-07-22—Roche CoaguChek XS System, CoaguChek XS PST Kit, Roche Diagnostics, Indianapolis, IN; Catalog/Model
2009-07-22—Roche CoaguChek XS System, CoaguChek XS Professional Care Kit, Roche Diagnostics, Indianapolis, IN;
0013-11-25—MagNA Pure 96 System Version 1.0 Software Version 2.0 Robotic workstation for automated isolation o