Roche Diagnostics Operations recalls
Roche Diagnostics Operations appears in 127 official U.S. recall notices indexed by RecallRadar.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- URISYS 2400 Urine Analyzer Automated Urinalysis System Product Usage: The RSD 800 is a computer-controlled stand-alone sorting system for s…
FDA Device · Class II · 2016-11-02 · Roche Diagnostics Operations - cobas p 612 Pre-Analytical Instrument calculator/data processing module, for clinical use Product Usage: The cobas 6000 series is a fully a…
FDA Device · Class II · 2016-11-02 · Roche Diagnostics Operations - cobas p 501 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The MODULAR PRE-ANALYTICS system is a f…
FDA Device · Class II · 2016-11-02 · Roche Diagnostics Operations - cobas e411 Immunoassay Analyzer e411: Immunoassay Analyzer Product Usage: The cobas p501/p701 instrument stores primary and secondary sampl…
FDA Device · Class II · 2016-11-02 · Roche Diagnostics Operations - cobas 6000 Series system c6000, Chemistry (Photometric, Discrete), for clinical Use
FDA Device · Class II · 2016-11-02 · Roche Diagnostics Operations - Roche/Hitachi MODULAR Analytics Combination Systems Modular D/P: Clinical Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinica…
FDA Device · Class II · 2016-11-02 · Roche Diagnostics Operations - cobas 6800/8800 system Hepatitis Viral B DNA Detection Product Usage: The cobas p512 pre-analytical system is a computer controlled fully a…
FDA Device · Class II · 2016-11-02 · Roche Diagnostics Operations - cobas p 512 Pre-Analytical Instrument calculator/data processing module, for clinical use Product Usage: The cobas 6800/8800 systems suppor…
FDA Device · Class II · 2016-11-02 · Roche Diagnostics Operations - RSD 800A Aliquoting System calculator/data processing module, for clinical use Product Usage: The Roche/Hitachi MODULAR Analytics System is…
FDA Device · Class II · 2016-11-02 · Roche Diagnostics Operations - RSD 800 Sorting System calculator/data processing module, for clinical use Product Usage: The cobas 8000 Modular Analyze Series is a fully…
FDA Device · Class II · 2016-11-02 · Roche Diagnostics Operations - cobas p 701 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The URISYS 2400 Analyzer is a fully aut…
FDA Device · Class II · 2016-11-02 · Roche Diagnostics Operations - Roche COBAS INTEGRA 800 /800 CTS Analyzer Analyzer, Chemistry (Photometric, Discrete for Clinical use Product Usage: The system cobas p612…
FDA Device · Class II · 2016-11-02 · Roche Diagnostics Operations - Modular Pre Analytics ( EVO/Plus) Product Usage: The RSD 800A is a computer-controlled stand-online system for decapping, aliquoting and so…
FDA Device · Class II · 2016-11-02 · Roche Diagnostics Operations - cobas 8000 Modular Analyzer Series c8000, Chemistry (Photometric, Discrete) for clinical use Modular e602: Immunoassay Analyzer Product Usa…
FDA Device · Class II · 2016-11-02 · Roche Diagnostics Operations - VS II Aliquoter System calculator/data processing module, for clinical use Product Usage: Elecysy 411 analyzer is a fully automated, random…
FDA Device · Class II · 2016-11-02 · Roche Diagnostics Operations - cobas p 312 Pre-Analytical System calculator/data processing module, for clinical use Product Usage: The cobas p471 system is an automatic…
FDA Device · Class II · 2016-11-02 · Roche Diagnostics Operations - cobas p 471 centrifuge unit calculator/data processing module, for clinical use Product Usage: The cobas p312 pre-analytical system is a co…
FDA Device · Class II · 2016-11-02 · Roche Diagnostics Operations - ONLINE TDM Vancomycin 100 tests
FDA Device · Class II · 2016-08-10 · Roche Diagnostics Operations - Estradiol II Elecsys and cobas e analyzers REF 03000079 190
FDA Device · Class II · 2016-04-06 · Roche Diagnostics Operations - Estradiol III
FDA Device · Class II · 2016-04-06 · Roche Diagnostics Operations - cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis
FDA Device · Class II · 2016-03-30 · Roche Diagnostics Operations - 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 Monito…
FDA Device · Class II · 2016-03-23 · Roche Diagnostics Operations - Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analy…
FDA Device · Class II · 2015-11-25 · Roche Diagnostics Operations - 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 i…
FDA Device · Class II · 2015-09-02 · Roche Diagnostics Operations - 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 i…
FDA Device · Class II · 2015-09-02 · Roche Diagnostics Operations - S2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184 Blood Gas and Electrolytes Analyzer
FDA Device · Class II · 2015-08-12 · Roche Diagnostics Operations - HDL-Cholesterol gen.3. For the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in serum and plasma
FDA Device · Class II · 2015-07-08 · Roche Diagnostics Operations - Creatinine Plus
FDA Device · Class II · 2015-07-08 · Roche Diagnostics Operations - Cholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vitro diagnostic reagent system intended for use on…
FDA Device · Class II · 2015-07-08 · Roche Diagnostics Operations - Cholesterol CHOD-PAP. In vitro diagnostic reagent system intended for use on the Hitachi systems for The quantitative determination of tota…
FDA Device · Class II · 2015-07-08 · Roche Diagnostics Operations - LDL-Cholesterol gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-density li…
FDA Device · Class II · 2015-07-08 · Roche Diagnostics Operations - HDL-Cholesterol plus gen.3
FDA Device · Class II · 2015-07-08 · Roche Diagnostics Operations - Triglycerides GPO. In vitro test for the quantitative determination of triglycerides in human serum and plasma on the COBAS Integra 800 and…
FDA Device · Class II · 2015-07-08 · Roche Diagnostics Operations - Lactate
FDA Device · Class II · 2015-07-08 · Roche Diagnostics Operations - Uric Acid plus ver.2 In vitro test for the quantitative determination of uric acid in human serum, plasma and urine or Roche/Hitachi MODULA…
FDA Device · Class II · 2015-07-08 · Roche Diagnostics Operations - LDL-Cholesterol plus gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-densi…
FDA Device · Class II · 2015-07-08 · Roche Diagnostics Operations - Triglycerides/Glycerol Blanked
FDA Device · Class II · 2015-07-08 · Roche Diagnostics Operations - Creatinine Plus ver. 2. Intended for use on COBAS INTEGRA systems , cobas c111, and cobas c systems for the quantitative determination of t…
FDA Device · Class II · 2015-07-08 · Roche Diagnostics Operations - Homocysteine test system - Homocysteine Reagent. 05385415190
FDA Device · Class II · 2015-05-27 · Roche Diagnostics Operations - Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
FDA Device · Class II · 2015-02-11 · Roche Diagnostics Operations - ACCU-CHEK Tender I 13/110 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of…
FDA Device · Class II · 2015-01-07 · Roche Diagnostics Operations - ACCU-CHEK Tender I 13/80 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of t…
FDA Device · Class II · 2015-01-07 · Roche Diagnostics Operations - ACCU-CHEK Tender I 17/80 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of t…
FDA Device · Class II · 2015-01-07 · Roche Diagnostics Operations - ACCU-CHEK Tender II 17/60 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surfac…
FDA Device · Class II · 2015-01-07 · Roche Diagnostics Operations - ACCU-CHEK Tender II 13/110 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surfa…
FDA Device · Class II · 2015-01-07 · Roche Diagnostics Operations - ACCU-CHEK Tender II 13/80 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surfac…
FDA Device · Class II · 2015-01-07 · Roche Diagnostics Operations - ACCU-CHEK Tender II 17/110 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surfa…
FDA Device · Class II · 2015-01-07 · Roche Diagnostics Operations - ACCU-CHEK Tender II 17/80 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surfac…
FDA Device · Class II · 2015-01-07 · Roche Diagnostics Operations - ACCU-CHEK Tender I 17/60 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of t…
FDA Device · Class II · 2015-01-07 · Roche Diagnostics Operations - ACCU-CHEK¿ Tender I 13/60 10 pieces Product Usage: Usage: Intended for the infusion and/or injection of fluids into the body below the surf…
FDA Device · Class II · 2015-01-07 · Roche Diagnostics Operations