Roche Diagnostics Operations, Inc.
84 recalls on record · Latest: Nov 27, 2024
FDA Devices Moderate Jul 8, 2015
Creatinine Plus ver. 2. Intended for use on COBAS INTEGRA systems , cobas c111, and cobas c systems for the quantitative determination of the crea…
FDA Devices Moderate Jul 8, 2015
HDL-Cholesterol plus gen.3.; and Small Supersized Intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for …
FDA Devices Moderate Jul 8, 2015
Uric Acid plus ver.2 In vitro test for the quantitative determination of uric acid in human serum, plasma and urine or Roche/Hitachi MODULAR syste…
FDA Devices Moderate Jul 8, 2015
Triglycerides/Glycerol Blanked. In vitro test for the quantitative determination of triglycerides in human serum and plasma or Roche/Hitachi MODUL…
FDA Devices Moderate Jul 8, 2015
Creatinine Plus. Intended for use on Hitachi/MODULAR systems for the quantitative determination of the creatinine concentration in serum, plasma, …
FDA Devices Moderate Jul 8, 2015
Lactate. Intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems for the quanti…
FDA Devices Moderate Jul 8, 2015
LDL-Cholesterol plus gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-density lip…
FDA Devices Moderate Jul 8, 2015
Cholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS I…
FDA Devices Moderate May 27, 2015
Homocysteine test system - Homocysteine Reagent. 05385415190; Homocysteine 100 Tests, cobas c, COBAS INTEGRA Homocysteine Enzymatic Assay is an i…
FDA Devices Moderate Feb 11, 2015
Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
FDA Devices Moderate Jan 7, 2015
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 surface of …
FDA Devices Moderate Jan 7, 2015
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 the ski…
FDA Devices Moderate Jan 7, 2015
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 surface of t…
FDA Devices Moderate Jan 7, 2015
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 the ski…
FDA Devices Moderate Jan 7, 2015
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 surface o…
FDA Devices Moderate Jan 7, 2015
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 surface of t…
FDA Devices Moderate Jan 7, 2015
ACCU-CHEK Tender I 17/110 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the sk…
FDA Devices Moderate Jan 7, 2015
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 surface of …
FDA Devices Moderate Jan 7, 2015
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 surface of t…
FDA Devices Moderate Nov 5, 2014
ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System Product Usage: The ACCU-CHEK Combo System is meant only for s…
FDA Devices Low Oct 22, 2014
Omni Micro-electrode/reference electrode for cobas b221 analyzer. The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyze…
FDA Devices Moderate Sep 10, 2014
Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laboratory data.
FDA Devices Moderate Jun 25, 2014
Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents…
FDA Devices Moderate Jun 25, 2014
cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product U…
FDA Devices Moderate May 21, 2014
ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Meters; 17 count sample strip 51 count retail strip; 102 count retail strip…
FDA Devices Moderate Apr 16, 2014
Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer intended for the in vitro quantitative / qual…
FDA Devices Moderate Apr 9, 2014
Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number: 03111873180 as a part of the following systems: 1. 03…
FDA Devices Moderate Sep 4, 2013
ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.
FDA Devices Moderate Jul 3, 2013
CoaguChek XS Pro System The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines prothrombin…
FDA Devices Moderate Jul 3, 2013
CoaguChek XS System (PST) The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System measures blood-clotting tim…
FDA Devices Moderate Jul 3, 2013
CoaguChek XS Plus System The CoaguChek XS Plus system for use by professional healthcare providers for quantitative prothrombin time testing for t…
FDA Devices Moderate Apr 24, 2013
CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the CoagCHEK XS Pro Meters to quantitatively determines prothrombi…
FDA Devices Moderate Apr 24, 2013
ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to quantitatively measure glucose …
FDA Devices Moderate Apr 10, 2013