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.
- ACCU-CHEK Tender II 13/60 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 I 17/110 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 Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System Product Usage: The ACCU-CHEK Combo System is meant only…
FDA Device · Class II · 2014-11-05 · Roche Diagnostics Operations - Omni Micro-electrode/reference electrode for cobas b221 analyzer
FDA Device · Class III · 2014-10-22 · Roche Diagnostics Operations - Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laboratory data
FDA Device · Class II · 2014-09-10 · Roche Diagnostics Operations - cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat
FDA Device · Class II · 2014-06-25 · Roche Diagnostics Operations - Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02
FDA Device · Class II · 2014-06-25 · Roche Diagnostics Operations - cobas 6000 analyzer series Operators Manual Roche cobas
FDA Device · Class II · 2014-06-25 · Roche Diagnostics Operations - ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Meters
FDA Device · Class II · 2014-05-21 · Roche Diagnostics Operations - Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer intended for the in vitro quantitativ…
FDA Device · Class II · 2014-04-16 · Roche Diagnostics Operations - Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number: 03111873180 as a part of the following systems…
FDA Device · Class II · 2014-04-09 · Roche Diagnostics Operations - MagNA Pure 96 System Version 1.0 Software Version 2.0 Robotic workstation for automated isolation of nucleic acids from different kinds of…
FDA Device · Class II · 2013-12-25 · Roche Diagnostics Operations - ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo System)\ The ACCU-CHEK Combo System is indicated for the…
FDA Device · Class II · 2013-12-04 · Roche Diagnostics Operations - COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas
FDA Device · Class II · 2013-11-13 · Roche Diagnostics Operations - ACCU-CHECK FastClix Lancing Device
FDA Device · Class II · 2013-09-04 · Roche Diagnostics Operations - B-CrossLaps/serum (B-CTx in serum) REF 11972308 160 100 tests Immunoassay for the in vitro quantitative determination of degradation produc…
FDA Device · Class II · 2013-07-24 · Roche Diagnostics Operations - CoaguChek XS System (PST) The CoaguChek XS PT test strips are part of the CoaguChek XS System
FDA Device · Class II · 2013-07-03 · Roche Diagnostics Operations - CoaguChek XS System (HCP) The CoaguChek XS System is intended for use by professional healthcare providers for quantitative prothrombin tim…
FDA Device · Class II · 2013-07-03 · Roche Diagnostics Operations - CoaguChek XS Pro System The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines prot…
FDA Device · Class II · 2013-07-03 · Roche Diagnostics Operations - CoaguChek XS Plus System The CoaguChek XS Plus system for use by professional healthcare providers for quantitative prothrombin time testin…
FDA Device · Class II · 2013-07-03 · Roche Diagnostics Operations - Cobas¿ 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module only
FDA Device · Class II · 2013-05-29 · Roche Diagnostics Operations - CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner
FDA Device · Class II · 2013-04-24 · Roche Diagnostics Operations - ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner
FDA Device · Class II · 2013-04-24 · Roche Diagnostics Operations - Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 05232732001
FDA Device · Class II · 2013-04-10 · Roche Diagnostics Operations - Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer
FDA Device · Class III · 2013-01-30 · Roche Diagnostics Operations - Cobas b 123 POC system cobas b 123 POC system is fully automated POC system for whole blood in vitro measurement of pH, blood gases (BG), e…
FDA Device · Class II · 2012-12-19 · Roche Diagnostics Operations - Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001
FDA Device · Class II · 2012-12-12 · Roche Diagnostics Operations