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Roche Diagnostics Operations, Inc. Recalls

80 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Roche Diagnostics Operations, Inc..

80Total Recalls
1Critical
2.3MUnits Affected
Jan 20, 2026Most Recent
All Recalls

Every Roche Diagnostics Operations, Inc. Recall

Sorted by most recent. Click any recall for full details.

80 recalls
High RiskFDA
Roche Diagnostics Operations, Inc.
Creatinine Plus ver. 2. Intended for use on COBAS INTEGRA systems , cobas c111, and cobas c systems for the quantitative determination...
Medical Devices·6,255 affected·May 7, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
HDL-Cholesterol plus gen.3.; and Small Supersized Intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c ...
Medical Devices·6,255 affected·May 7, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
Uric Acid plus ver.2 In vitro test for the quantitative determination of uric acid in human serum, plasma and urine or Roche/Hitachi M...
Medical Devices·6,255 affected·May 7, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
Triglycerides/Glycerol Blanked. In vitro test for the quantitative determination of triglycerides in human serum and plasma or Roche/H...
Medical Devices·6,255 affected·May 7, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
Creatinine Plus. Intended for use on Hitachi/MODULAR systems for the quantitative determination of the creatinine concentration in ser...
Medical Devices·6,255 affected·May 7, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
Lactate. Intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems fo...
Medical Devices·6,255 affected·May 7, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
LDL-Cholesterol plus gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low...
Medical Devices·6,255 affected·May 7, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
Cholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vitro diagnostic reagent system intended for us...
Diagnostic Devices·6,255 affected·May 7, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
Homocysteine test system - Homocysteine Reagent. 05385415190; Homocysteine 100 Tests, cobas c, COBAS INTEGRA Homocysteine Enzymatic A...
Diagnostic Devices·2,558 affected·Mar 23, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
Medical Devices·103 affected·Dec 18, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
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...
Surgical Devices·13,041 affected·Nov 20, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
ACCU-CHEK Tender I 17/80 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surfac...
Surgical Devices·13,041 affected·Nov 20, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
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 ...
Surgical Devices·13,041 affected·Nov 20, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
ACCU-CHEK Tender I 17/60 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surfac...
Surgical Devices·13,041 affected·Nov 20, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
ACCU-CHEK¿ Tender I 13/60 10 pieces Product Usage: Usage: Intended for the infusion and/or injection of fluids into the body below t...
Surgical Devices·13,041 affected·Nov 20, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
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 ...
Surgical Devices·13,041 affected·Nov 20, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
ACCU-CHEK Tender I 17/110 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surfa...
Surgical Devices·13,041 affected·Nov 20, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System Product Usage: The ACCU-CHEK Combo System is mean...
Diabetes Devices·8,116 affected·Sep 25, 2014
RecallFDA
Roche Diagnostics Operations, Inc.
Omni Micro-electrode/reference electrode for cobas b221 analyzer. The Roche Diagnostics Omni S Analyzer is a fully automated critical ...
Diabetes Devices·492 affected·Sep 12, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laboratory data.
Medical Devices·148 affected·Jul 31, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 031497730...
Diagnostic Devices·462 affected·May 21, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) ...
Diagnostic Devices·149 affected·May 21, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Meters; 17 count sample strip 51 count retail strip; 102 count ...
Diabetes Devices·590,136 affected·Apr 14, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer intended for the in vitro quantit...
Medical Devices·76 affected·Mar 13, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number: 03111873180 as a part of the following sys...
Diabetes Devices·0 affected·Feb 28, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.
Diabetes Devices·36,332 affected·Aug 19, 2013
High RiskFDA
Roche Diagnostics Operations, Inc.
CoaguChek XS Pro System The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines...
Medical Devices·537 affected·May 16, 2013
High RiskFDA
Roche Diagnostics Operations, Inc.
CoaguChek XS System (PST) The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System measures blood-...
Medical Devices·204,205 affected·May 16, 2013
High RiskFDA
Roche Diagnostics Operations, Inc.
CoaguChek XS Plus System The CoaguChek XS Plus system for use by professional healthcare providers for quantitative prothrombin time t...
Medical Devices·3,343 affected·May 16, 2013
High RiskFDA
Roche Diagnostics Operations, Inc.
CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the CoagCHEK XS Pro Meters to quantitatively determine...
Medical Devices·4,467 affected·Mar 6, 2013
High RiskFDA
Roche Diagnostics Operations, Inc.
ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to quantitatively meas...
Diabetes Devices·4,467 affected·Mar 6, 2013
High RiskFDA
Roche Diagnostics Operations, Inc.
Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 05232732001. Used with the cobas¿ CT/NG 4800 System, ...
Diagnostic Devices·189 affected·Mar 1, 2013