Roche Diagnostics Operations recalls
Roche Diagnostics Operations appears in 127 official U.S. recall notices indexed by RecallRadar, most recently on 2026-03-11.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001 cobas pro SSU,…
FDA Device · Class II · 2026-03-11 · Roche Diagnostics Operations - The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminesce…
FDA Device · Class II · 2026-01-14 · Roche Diagnostics Operations - cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocystei…
FDA Device · Class II · 2024-11-27 · Roche Diagnostics Operations - Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination of creatine ki…
FDA Device · Class II · 2024-10-02 · Roche Diagnostics Operations - Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502
FDA Device · Class II · 2023-11-29 · Roche Diagnostics Operations - cobas infinity central lab, Material Number 07154003001
FDA Device · Class II · 2023-01-18 · Roche Diagnostics Operations - cobas e801 Immunoassay Analyzer
FDA Device · Class II · 2022-08-17 · Roche Diagnostics Operations - Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 601 urinalysis test system is comprised of the cobas u 601 urine…
FDA Device · Class II · 2021-11-24 · Roche Diagnostics Operations - cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
FDA Device · Class II · 2021-09-22 · Roche Diagnostics Operations - IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for the quantitative dete…
FDA Device · Class II · 2021-06-02 · Roche Diagnostics Operations - Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction
FDA Device · Class II · 2021-05-26 · Roche Diagnostics Operations - Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction
FDA Device · Class II · 2021-05-26 · Roche Diagnostics Operations - 9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and lith…
FDA Device · Class II · 2021-02-17 · Roche Diagnostics Operations - A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data Catal…
FDA Device · Class II · 2021-01-27 · Roche Diagnostics Operations - CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications such…
FDA Device · Class II · 2021-01-13 · Roche Diagnostics Operations - CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin time testing for the monitoring…
FDA Device · Class II · 2021-01-13 · Roche Diagnostics Operations - Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units) Chemistry Analyzer (photometric discret…
FDA Device · Class II · 2021-01-06 · Roche Diagnostics Operations - cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
FDA Device · Class II · 2021-01-06 · Roche Diagnostics Operations - Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module
FDA Device · Class II · 2021-01-06 · Roche Diagnostics Operations - Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quantitative determination of CRP in human se…
FDA Device · Class II · 2020-12-23 · Roche Diagnostics Operations - cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be used for the configura…
FDA Device · Class II · 2020-11-25 · Roche Diagnostics Operations - Albumin Gen.2, Catalog 05166861190
FDA Device · Class III · 2020-10-21 · Roche Diagnostics Operations - Tina-quant Complement C4 ver.2, Catalog 05991994190
FDA Device · Class III · 2020-10-21 · Roche Diagnostics Operations - BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001
FDA Device · Class II · 2020-10-14 · Roche Diagnostics Operations - DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001
FDA Device · Class II · 2020-10-14 · Roche Diagnostics Operations - Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190
FDA Device · Class II · 2020-09-23 · Roche Diagnostics Operations - Elecsys CA 19-9, Cat
FDA Device · Class II · 2020-03-11 · Roche Diagnostics Operations - cobas infinity core, Material No. 7154003001
FDA Device · Class II · 2020-02-19 · Roche Diagnostics Operations - Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical Use Material Number: 07154003001
FDA Device · Class II · 2020-02-05 · Roche Diagnostics Operations - Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi coba…
FDA Device · Class II · 2019-12-25 · Roche Diagnostics Operations - Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and…
FDA Device · Class II · 2019-12-18 · Roche Diagnostics Operations - Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative determination of the total bi…
FDA Device · Class III · 2019-10-23 · Roche Diagnostics Operations - Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determination…
FDA Device · Class III · 2019-10-23 · Roche Diagnostics Operations - cobas c 311
FDA Device · Class II · 2019-10-16 · Roche Diagnostics Operations - Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502
FDA Device · Class II · 2019-10-16 · Roche Diagnostics Operations - Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Module: cobas c 311 and cobas c 501/502
FDA Device · Class II · 2019-10-16 · Roche Diagnostics Operations - AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determi…
FDA Device · Class II · 2019-10-16 · Roche Diagnostics Operations - cobas c 701 and 702 Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 05950821190
FDA Device · Class II · 2019-10-16 · Roche Diagnostics Operations - The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay for the quantitative in vitro determination of myoglobin in h…
FDA Device · Class II · 2019-09-11 · Roche Diagnostics Operations - cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001
FDA Device · Class II · 2019-09-11 · Roche Diagnostics Operations - cobas c513 Analyzer
FDA Device · Class II · 2019-09-11 · Roche Diagnostics Operations - Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 module part Numbers : 05641489001 cobas c…
FDA Device · Class II · 2019-09-11 · Roche Diagnostics Operations - Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160
FDA Device · Class II · 2019-09-04 · Roche Diagnostics Operations - Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190
FDA Device · Class II · 2019-09-04 · Roche Diagnostics Operations - 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 gases (…
FDA Device · Class II · 2017-02-01 · Roche Diagnostics Operations - Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) The Tina-Quant CRP (Latex) High Sensitive Immunoturbidimetric…
FDA Device · Class II · 2017-02-01 · Roche Diagnostics Operations - 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 Ana…
FDA Device · Class II · 2016-12-07 · Roche Diagnostics Operations - Tina-Quant Hemoglobin A1c Gen. 2 Hemoglobin A1c test Catalog number 04528123190 / 05401640190
FDA Device · Class II · 2016-11-23 · Roche Diagnostics Operations - COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test Catalog number 04528123160
FDA Device · Class II · 2016-11-23 · Roche Diagnostics Operations - Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Product Usage: The Roche COBAS INTEGRA c111 analyzer…
FDA Device · Class II · 2016-11-16 · Roche Diagnostics Operations