Roche Diagnostics Corp.
Indianapolis, IN
This page shows every FDA and USDA recall linked to Roche Diagnostics Corp.. 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.
201
Total Recalls
2002
First Recall
2009
Most Recent
Roche ACCU-CHEK Performa blood glucose meters/kits, Roche Diagnostics, Indianapolis, IN.
Test strips for qu...
Sep 16, 2009
· Device
Terminated
Roche ACCU-CHEK Performa blood glucose test strips, Roche Diagnostics, Indianapolis, IN.
Test strips for qu...
Sep 16, 2009
· Device
Terminated
Roche/Hitachi Preciset TDM I, Roche Diagnostics, Indianapolis, IN; Catalog No. 03375790 190.
Calibrator des...
Sep 10, 2009
· Device
Terminated
Roche/Hitachi Preciset TDM II, Roche Diagnostics, Indianapolis, IN; Catalog No. 03375781 190.
Calibrator de...
Sep 10, 2009
· Device
Terminated
Roche Coaguchex XS Systems for Patient Self-Testing, Roche Diagnostics, Indianapolis, IN; REF 04837738001 incl...
Aug 11, 2009
· Device
Terminated
Roche ACCU-CHEK Compact Plus Meter Kit, Roche Diagnostics, Indianapolis, IN; REFS 03149137001, 05177294001 and...
Aug 11, 2009
· Device
Terminated
Roche ACCU-Chek Voicemate Meter, Roche Diagnostics, Indianapolis, IN; REF 12030802001 includes the Roche ACCU-...
Aug 11, 2009
· Device
Terminated
Roche ACCU-Chek Active Meter Kit, Roche Diagnostics, Indianapolis, IN; REF 03184501001 includes the Roche ACCU...
Aug 11, 2009
· Device
Terminated
Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Models 314484400...
Aug 11, 2009
· Device
Terminated
Roche ACCU-Chek Aviva Meter Kit, Roche Diagnostics, Indianapolis, IN; REF 04893247001 includes the Roche ACCU-...
Aug 11, 2009
· Device
Terminated
Roche cobas 6000 analyzer series (including cobas c 501 and cobas e 601 modules) Middleware Solutions Instrume...
May 20, 2009
· Device
Terminated
Roche cobas 6000 analyzer series (including cobas c 501 and cobas e 601 modules) Middleware Solutions Instrume...
May 20, 2009
· Device
Terminated
Roche MagNA Pure LC Workstation; Product Numbers: 12236931001, 12236931444, 12236931692 and 03670325001. Robo...
May 18, 2009
· Device
Terminated
Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular D Module, Roche Diagnostics Corp....
Apr 10, 2009
· Device
Terminated
Roche/Hitachi Modular Analytics System, clinical chemistry analyzer Modular D2400 Module, Roche Diagnostics C...
Apr 10, 2009
· Device
Terminated
Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular P Module, Roche Diagnostics Corp....
Apr 10, 2009
· Device
Terminated
Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular P800 Module, Roche Diagnostics Co...
Apr 10, 2009
· Device
Terminated
Roche COBAS c 111 Analyzer with ISE module option, GMMI No. 04777433001; Roche Diagnostics, Indianapolis, IN....
Mar 24, 2009
· Device
Terminated
Roche ISE Internal Standard Gen.2 for use on Roche cobas c systems, Roche Diagnostics, Inc., Indpls., IN; Cata...
Jan 6, 2009
· Device
Terminated
Roche/Hitachi Modular E Module immunoassay analyzer, Roche Diagnostics, Ind., IN; GMMI Nos. 04998642001 and 03...
Oct 22, 2008
· Device
Terminated
Roche Diagnostics STFR Tina-quant Soluble Transferrin Receptor, COBAS INTEGRA, cobas c systems, Roche Diagnost...
Oct 9, 2008
· Device
Terminated
Roche Diagnostics HDLC3, HDL-Cholesterol Plus 3rd Generation, COBAS INTEGRA, cobas c systems, Roche Diagnostic...
Oct 9, 2008
· Device
Terminated
Roche Diagnostics NAPA2, N-Acetyl-Procainamide, COBAS INTEGRA, Roche Diagnostics, Indianapolis, IN.; 207378523...
Oct 9, 2008
· Device
Terminated
Roche Diagnostics ALBT2, Tina-quant Albumin Gen. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indiana...
Oct 9, 2008
· Device
Terminated
Roche Diagnostics LDL_C, LDL- Cholesterol Plus 2nd generation, COBAS INTEGRA, cobas c systems, Roche Diagnosti...
Oct 9, 2008
· Device
Terminated
Roche Diagnostics CREP2, Creatinine Plus Ver. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapol...
Oct 9, 2008
· Device
Terminated
Roche Diagnostics IRON2, Iron Gen. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03...
Oct 9, 2008
· Device
Terminated
Roche/Hitachi Modular Analytics System, Modular D Module GMMI clinical chemistry analyzer; Catalog number 0328...
Aug 13, 2008
· Device
Terminated
Roche/Hitachi Modular Analytics System, Modular D2400 Module GMMI clinical chemistry analyzer; Catalog number...
Aug 13, 2008
· Device
Terminated
Roche/Hitachi Modular Analytics System Modular P Module GMMI immunoassay analyzer; Catalog number 03284549001....
Aug 13, 2008
· Device
Terminated
Roche/Hitachi Modular Analytics System, Modular P800 Module GMMI clinical chemistry analyzer; Catalog number 0...
Aug 13, 2008
· Device
Terminated
Roche/Hitachi Modular Analytics System, Modular E Module GMMI immunoassay analyzer; Catalog numbers 049986420...
Aug 13, 2008
· Device
Terminated
Roche COBAS 6000 Clinical Chemistry analyzer; Catalog Number: 04745914001, Roche Diagnostics Corporation, Indi...
Mar 4, 2008
· Device
Terminated
Roche LIPC Lipase Colorimetric Reagent; Catalog Number: 03029590322. Roche Diagnostics Corp., Indianapolis, I...
Feb 8, 2008
· Device
Terminated
Roche Ammonia/Ethanol/CO2 Calibrator for use in conjunction with Roche/Hitachi, COBAS INTEGRA, cobas c111 and...
Dec 29, 2007
· Device
Terminated
Roche Ammonia/Ethanol/CO2 Control N (Normal) for use in conjunction with Roche/Hitachi, COBAS INTEGRA, cobas c...
Dec 29, 2007
· Device
Terminated
Roche Ammonia/Ethanol/CO2 Control A (Abnormal) for use in conjunction with Roche/Hitachi, COBAS INTEGRA, cobas...
Dec 29, 2007
· Device
Terminated
Roche Diagnostics LightCycler Capillaries (100uL) for use in conjunction with the LightCycler analyzers; Catal...
Dec 12, 2007
· Device
Terminated
Roche Cortisol reagent for use in conjunction with Roche cobas e 411, cobas e 601, Elecsys 1010, Elecsys 2010...
Jun 28, 2007
· Device
Terminated
MagNA Pure LC Total Nucleic Acid Isolation Kit - Large Volume; Catalog # 03264793001.
Jun 22, 2007
· Device
Terminated
Roche VANC2, Online TDM Vancomycin, for use with the Roche/Hitachi Cobas c 501analyzer; Catalog No.04491050190...
Jun 9, 2007
· Device
Terminated
Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 911,912, 917 and Modular P; Catalog No. 046425...
Jun 9, 2007
· Device
Terminated
Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 917 and Modular P; catalog no. 04642503190111...
Jun 9, 2007
· Device
Terminated
Roche VALP2, Online TDM Valproic acid , for use with the Roche/Hitachi Cobas c 501 analyzer; Catalog No.044910...
Jun 9, 2007
· Device
Terminated
Roche PTH (parathyroid hormone test system) for use in conjunction with Roche cobas e 411, cobas e 601, Elecsy...
May 16, 2007
· Device
Terminated
Roche COBAS Integra DIG, Digoxin Reagent for use on the COBAS INTEGRA models 400, 400 plus, 700 and 800 analyz...
Apr 13, 2007
· Device
Terminated
CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use).
Apr 11, 2007
· Device
Terminated
Roche IGGT COBAS INTEGRA Immunoglobulin G (Turbidimetric); Catalog no. 20766631322. in vitro diagnostic.
Jan 17, 2007
· Device
Terminated
CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use), 3116239 (12 stri...
Nov 30, 2006
· Device
Terminated
Roche Elecsys Folate II for use on Elecsys 210 Analyzers; Catalog No. 3253678 (Roche Material No. 03253678122.
Sep 29, 2006
· Device
Terminated