Roche Diagnostics Operations, Inc.
Indianapolis, IN
This page shows every FDA and USDA recall linked to Roche Diagnostics Operations, Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
151
Total Recalls
0013
First Recall
2026
Most Recent
ACCU-CHEK Tender I 17/60 10 pieces
Product Usage:
Intended for the infusion and/or injection of fluids into t...
Dec 30, 2014
· Device
Terminated
ACCU-CHEK Tender I 17/80 10 pieces
Product Usage:
Intended for the infusion and/or injection of fluids into t...
Dec 30, 2014
· Device
Terminated
ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System
Product Usage:
The ACCU-C...
Oct 29, 2014
· Device
Terminated
Omni Micro-electrode/reference electrode for cobas b221 analyzer.
The Roche Diagnostics Omni S Analyzer is a...
Oct 10, 2014
· Device
Terminated
Roche cobas IT 1000
Product Usage: Intended Use: An electronic device intended to store, retrieve, and proce...
Sep 1, 2014
· Device
Terminated
cobas 8000 analyzer series Operators Manual Roche cobas
Filter label: Filter (N) Mat. No 03149773001, Conte...
Jun 14, 2014
· Device
Terminated
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Cont...
Jun 14, 2014
· Device
Terminated
Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Fi...
Jun 14, 2014
· Device
Terminated
ACCU-CHEK Compact Plus Test Strips
For use with: ACCU-CHEK Compact Plus Meters; 17 count sample strip
51 count...
May 13, 2014
· Device
Terminated
Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer intend...
Apr 10, 2014
· Device
Terminated
Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number:
03111873180 as a...
Apr 2, 2014
· Device
Terminated
MagNA Pure 96 System
Version 1.0
Software Version 2.0
Robotic workstation for automated isolation of nucleic...
Dec 18, 2013
· Device
Terminated
ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo System)\
The ACCU-CHEK Comb...
Nov 22, 2013
· Device
Terminated
COBAS INTEGRA 800 Analyzer with software 9864.C2
Cobas. COBAS Part Numbers 28122474001, 28122474692, 04559126...
Nov 5, 2013
· Device
Terminated
ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring syst...
Aug 28, 2013
· Device
Terminated
B-CrossLaps/serum (B-CTx in serum)
REF 11972308 160
100 tests
Immunoassay for the in vitro quantitative dete...
Jul 12, 2013
· Device
Terminated
CoaguChek XS Pro System
The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips)...
Jun 24, 2013
· Device
Terminated
CoaguChek XS Plus System
The CoaguChek XS Plus system for use by professional healthcare providers for quanti...
Jun 24, 2013
· Device
Terminated
CoaguChek XS System (HCP)
The CoaguChek XS System is intended for use by professional healthcare providers fo...
Jun 24, 2013
· Device
Terminated
CoaguChek XS System (PST)
The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek...
Jun 24, 2013
· Device
Terminated
Cobas 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module onl...
May 23, 2013
· Device
Terminated
CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner.
Used with the CoagCHEK XS Pro Meters to...
Apr 15, 2013
· Device
Terminated
ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner.
Used with the ACCU-CHEK Inform II Syst...
Apr 15, 2013
· Device
Terminated
Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 05232732001. Used with the...
Apr 1, 2013
· Device
Terminated
Roche COBAS INTEGRA 400 and 400 plus Analyzer,
an in vitro diagnostic analyzer.
Jan 18, 2013
· Device
Terminated
Cobas b 123 POC system
cobas b 123 POC system is fully automated POC system for whole blood in vitro measurem...
Dec 13, 2012
· Device
Terminated
Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automate...
Dec 4, 2012
· Device
Terminated
Elecsys Troponin I Immunoassay
For the in-vitro quantitative determination of cardiac troponin I in human ser...
Apr 11, 2012
· Device
Terminated
Elecsys Troponin I STAT Immunoassay
For the in-vitro quantitative determination of cardiac troponin I in huma...
Apr 11, 2012
· Device
Terminated
ACCU-CHEK Aviva Nano Blood Glucose Meter
No product labeling, beyond the labels applied to the meter, was pr...
Apr 9, 2012
· Device
Terminated
Elecsys 2010 Analyzer Software version 06-07
The Elecsys 2010 analyzer is intended for the in vitro quantitat...
Mar 16, 2012
· Device
Terminated
cobas c 311 Analyzer, Part Number: 04826876001
In-vitro diagnostic analyzer capable of performing clinical ch...
Nov 30, 2011
· Device
Terminated
Roche Cobas c 111 Analyzer
The Roche Cobas c 111 analyzer is an in-vitro diagnostic analyzer capable of perfor...
Nov 30, 2011
· Device
Terminated
MagNA Pure LC 1.0 (software version 3.0.11).
Roche Diagnostics Operations, Inc.
An automated instrument used...
Aug 29, 2011
· Device
Terminated
MagNA Pure LC 2.0 (software version 1.1.23 and 1.1.24)
Roche Diagnostics Operations, Inc.
An automated instru...
Aug 29, 2011
· Device
Terminated
ACCU-CHECK PERFORMA STRIP NO. 05987288031, 100 BANDELETTES REACTIVES, ROCHE DIAGNOSTICS GMBH, WWW.ACCUCHEK.COM...
Jun 21, 2011
· Device
Terminated
Cyclosporine Sample Pretreatment Reagent, COBAS INTEGRA, IVD, Roche Diagnostics GmbH, Assembled for and Distri...
Apr 15, 2011
· Device
Terminated
Calcium Reagent, Calcium Test System for cobas c 111, Part number 04718933190, Roche Diagnostics Corpora...
Mar 25, 2011
· Device
Terminated
Calcium Reagent, Calcium Test System for COBAS INTEGRA 400, 400 PLUS, 800, 800 CTS, cobas c 311, 501 and 50...
Mar 25, 2011
· Device
Terminated
Acetaminophen Test System for use on the Roche/Hitachi, part number 03255379190, Roche Diagnostics Corporatio...
Mar 16, 2011
· Device
Terminated
Acetaminophen Test System for use on the COBAS/INTEGRA/cobas c, part number 20767174322, Roche Diagnostics C...
Mar 16, 2011
· Device
Terminated
Factor II (prothrombin) G20210A kit, catalog number 03610195001, Roche Diagnostics, Indianapolis, IN
The...
Mar 14, 2011
· Device
Terminated
Factor V Leiden kit catalog number 03610179001, Roche Diagnostics, Indianapolis, IN
The Factor V Leiden Kit...
Mar 14, 2011
· Device
Terminated
MagNA Pure LC 2.0 Instrument, catalog number 05197686001, Roche Diagnostics, Indianapolis, IN
MagNA Pure LC...
Mar 14, 2011
· Device
Terminated
ONLINE TDM N-acetylprocainamide, Part number 04642520190 N- acetylprocainamide reagent Roche Diagnostics Corp...
Sep 8, 2010
· Device
Terminated
Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 917 and Modular P; Catalog no. 03500241190...
Mar 8, 2010
· Device
Terminated
Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 911, 912, 917 and Modular P; Catalog no. 0...
Mar 8, 2010
· Device
Terminated
Roche/Hitachi GENT2 ONLINE TDM Gentamicin for Roche cobas c 501 analyzer systems; Catalog no. 04490843190.
T...
Mar 8, 2010
· Device
Terminated
Roche CoaguChek XS System, CoaguChek XS Plus Care Kit, Roche Diagnostics, Indianapolis, IN; Model Number 05021...
Sep 3, 2009
· Device
Terminated
Roche CoaguChek XS System, CoaguChek XS PST Kit, Roche Diagnostics, Indianapolis, IN; Catalog/Model Number 048...
Sep 3, 2009
· Device
Terminated