Roche Diagnostics Operations, Inc.
84 recalls on record · Latest: Nov 27, 2024
FDA Devices Moderate Nov 27, 2024
cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
FDA Devices Moderate Nov 29, 2023
Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEGRA 400 p…
FDA Devices Moderate Jan 18, 2023
cobas infinity central lab, Material Number 07154003001
FDA Devices Moderate Aug 17, 2022
cobas e801 Immunoassay Analyzer
FDA Devices Moderate Nov 24, 2021
Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 601 urinalysis test system is comprised of the cobas u 601 urine analyzer…
FDA Devices Moderate Sep 22, 2021
cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
FDA Devices Moderate Jun 2, 2021
IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for the quantitative determination …
FDA Devices Moderate May 26, 2021
Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
FDA Devices Moderate Feb 17, 2021
9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and lithium in the…
FDA Devices Moderate Jan 13, 2021
CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications such as Coumad…
FDA Devices Moderate Jan 13, 2021
CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfar…
FDA Devices Moderate Jan 6, 2021
cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
FDA Devices Moderate Jan 6, 2021
Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units) Chemistry Analyzer (photometric discrete), for cl…
FDA Devices Moderate Nov 25, 2020
cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be used for the configuration and c…
FDA Devices Low Oct 21, 2020
Albumin Gen.2, Catalog 05166861190
FDA Devices Low Oct 21, 2020
Tina-quant Complement C4 ver.2, Catalog 05991994190
FDA Devices Moderate Oct 14, 2020
DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001
FDA Devices Moderate Oct 14, 2020
BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001
FDA Devices Moderate Mar 11, 2020
Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer
FDA Devices Moderate Dec 25, 2019
Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c system…
FDA Devices Moderate Dec 18, 2019
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 plasma C…
FDA Devices Low Oct 23, 2019
Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determination of the a…
FDA Devices Moderate Oct 16, 2019
Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502
FDA Devices Moderate Oct 16, 2019
cobas c 701 and 702 Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 05950821190
FDA Devices Moderate Sep 11, 2019
cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001
FDA Devices Moderate Sep 11, 2019
The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay for the quantitative in vitro determination of myoglobin in human serum…
FDA Devices Moderate Sep 11, 2019
cobas c513 Analyzer
FDA Devices Moderate Sep 11, 2019
Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 module part Numbers : 05641489001 cobas c 702 …
FDA Devices Moderate Sep 4, 2019
Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160
FDA Devices Moderate Feb 1, 2017
Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) The Tina-Quant CRP (Latex) High Sensitive Immunoturbidimetric assay i…
FDA Devices Moderate Feb 1, 2017
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 (B3G), ele…
FDA Devices Moderate Dec 7, 2016
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 Analyzer is…
FDA Devices Moderate Nov 23, 2016
COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test Catalog number 04528123160
FDA Devices Moderate Nov 16, 2016
Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Product Usage: The Roche COBAS INTEGRA c111 analyzer is a…
FDA Devices Moderate Nov 2, 2016
Roche/Hitachi MODULAR Analytics Combination Systems Modular D/P: Clinical Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use. Mo…
FDA Devices Moderate Nov 2, 2016
cobas p 471 centrifuge unit calculator/data processing module, for clinical use Product Usage: The cobas p312 pre-analytical system is a compute…
FDA Devices Moderate Nov 2, 2016
cobas p 701 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The URISYS 2400 Analyzer is a fully automate…
FDA Devices Moderate Nov 2, 2016
VS II Aliquoter System calculator/data processing module, for clinical use Product Usage: Elecysy 411 analyzer is a fully automated, random acce…
FDA Devices Moderate Nov 2, 2016
URISYS 2400 Urine Analyzer Automated Urinalysis System Product Usage: The RSD 800 is a computer-controlled stand-alone sorting system for sortin…
FDA Devices Moderate Nov 2, 2016
RSD 800 Sorting System calculator/data processing module, for clinical use Product Usage: The cobas 8000 Modular Analyze Series is a fully autom…
FDA Devices Moderate Nov 2, 2016
cobas p 501 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The MODULAR PRE-ANALYTICS system is a fully …
FDA Devices Moderate Nov 2, 2016
cobas p 512 Pre-Analytical Instrument calculator/data processing module, for clinical use Product Usage: The cobas 6800/8800 systems support an …
FDA Devices Moderate Aug 10, 2016
ONLINE TDM Vancomycin 100 tests; ONLINE TDM Vancomycin 200 tests; Hitachi Vancomycin (Modular P); Hitachi Vancomycin (917, MOD P) The ONLINE TDM V…
FDA Devices Moderate Apr 6, 2016
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 micropartic…
FDA Devices Moderate Mar 30, 2016
cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.
FDA Devices Moderate Mar 23, 2016
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 Monitoring Syst…
FDA Devices Moderate Sep 2, 2015
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 blood in vitr…
FDA Devices Moderate Sep 2, 2015
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 blood in vitr…
FDA Devices Moderate Aug 12, 2015
S2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184 Blood Gas and Electrolytes Analyzer; The Roche Diagnostics Omni S Analyzer is …
FDA Devices Moderate Jul 8, 2015