FDA Device Recalls

Recalls / Firms / Roche Diagnostics Corp.

Roche Diagnostics Corp.

201 FDA device recalls on record.

DateClassProductReason
2009-06-10Roche ACCU-CHEK Performa blood glucose meters/kits, Roche Diagnostics, Indianapolis, IN. Test str
2009-06-10Roche ACCU-CHEK Performa blood glucose test strips, Roche Diagnostics, Indianapolis, IN. Test str
2009-05-13Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Models
2009-05-13Roche Coaguchex XS Systems for Patient Self-Testing, Roche Diagnostics, Indianapolis, IN; REF 048377
2009-05-13Roche ACCU-Chek Aviva Meter Kit, Roche Diagnostics, Indianapolis, IN; REF 04893247001 includes the R
2009-05-13Roche ACCU-CHEK Compact Plus Meter Kit, Roche Diagnostics, Indianapolis, IN; REFS 03149137001, 05177
2009-05-13Roche ACCU-Chek Voicemate Meter, Roche Diagnostics, Indianapolis, IN; REF 12030802001 includes the R
2009-05-13Roche ACCU-Chek Active Meter Kit, Roche Diagnostics, Indianapolis, IN; REF 03184501001 includes the
2009-04-22Roche/Hitachi Preciset TDM II, Roche Diagnostics, Indianapolis, IN; Catalog No. 03375781 190. Cal
2009-04-22Roche/Hitachi Preciset TDM I, Roche Diagnostics, Indianapolis, IN; Catalog No. 03375790 190. Cali
2009-04-01Roche cobas 6000 analyzer series (including cobas c 501 and cobas e 601 modules) Middleware Solution
2009-04-01Roche cobas 6000 analyzer series (including cobas c 501 and cobas e 601 modules) Middleware Solution
2009-02-09Roche MagNA Pure LC Workstation; Product Numbers: 12236931001, 12236931444, 12236931692 and 03670325
2008-11-17Roche COBAS c 111 Analyzer with ISE module option, GMMI No. 04777433001; Roche Diagnostics, Indianap
2008-11-12Roche/Hitachi Modular Analytics System, clinical chemistry analyzer Modular D2400 Module, Roche Dia
2008-11-12Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular P800 Module, Roche Diag
2008-11-12Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular P Module, Roche Diagnos
2008-11-12Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular D Module, Roche Diagnos
2008-09-15Roche ISE Internal Standard Gen.2 for use on Roche cobas c systems, Roche Diagnostics, Inc., Indpls.
2008-06-24Roche/Hitachi Modular E Module immunoassay analyzer, Roche Diagnostics, Ind., IN; GMMI Nos. 04998642
2008-06-11Roche Diagnostics NAPA2, N-Acetyl-Procainamide, COBAS INTEGRA, Roche Diagnostics, Indianapolis, IN.;
2008-06-11Roche Diagnostics LDL_C, LDL- Cholesterol Plus 2nd generation, COBAS INTEGRA, cobas c systems, Roche
2008-06-11Roche Diagnostics HDLC3, HDL-Cholesterol Plus 3rd Generation, COBAS INTEGRA, cobas c systems, Roche
2008-06-11Roche Diagnostics ALBT2, Tina-quant Albumin Gen. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostic
2008-06-11Roche Diagnostics STFR Tina-quant Soluble Transferrin Receptor, COBAS INTEGRA, cobas c systems, Roch
2008-06-11Roche Diagnostics IRON2, Iron Gen. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapoli
2008-06-11Roche Diagnostics CREP2, Creatinine Plus Ver. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics,
2008-03-21Roche/Hitachi Modular Analytics System Modular P Module GMMI immunoassay analyzer; Catalog number 03
2008-03-21Roche/Hitachi Modular Analytics System, Modular D2400 Module GMMI clinical chemistry analyzer; Catal
2008-03-21Roche/Hitachi Modular Analytics System, Modular D Module GMMI clinical chemistry analyzer; Catalog n
2008-03-21Roche/Hitachi Modular Analytics System, Modular E Module GMMI immunoassay analyzer; Catalog numbers
2008-03-21Roche/Hitachi Modular Analytics System, Modular P800 Module GMMI clinical chemistry analyzer; Catalo
2007-12-04Roche COBAS 6000 Clinical Chemistry analyzer; Catalog Number: 04745914001, Roche Diagnostics Corpora
2007-12-03Roche LIPC Lipase Colorimetric Reagent; Catalog Number: 03029590322. Roche Diagnostics Corp., India
2007-11-14Roche Ammonia/Ethanol/CO2 Calibrator for use in conjunction with Roche/Hitachi, COBAS INTEGRA, cobas
2007-11-14Roche Ammonia/Ethanol/CO2 Control A (Abnormal) for use in conjunction with Roche/Hitachi, COBAS INTE
2007-11-14Roche Ammonia/Ethanol/CO2 Control N (Normal) for use in conjunction with Roche/Hitachi, COBAS INTEGR
2007-08-30Roche Diagnostics LightCycler Capillaries (100uL) for use in conjunction with the LightCycler analyz
2007-05-15Roche Cortisol reagent for use in conjunction with Roche cobas e 411, cobas e 601, Elecsys 1010, Ele
2007-05-14MagNA Pure LC Total Nucleic Acid Isolation Kit - Large Volume; Catalog # 03264793001.
2007-04-30Roche VANC2, Online TDM Vancomycin, for use with the Roche/Hitachi Cobas c 501analyzer; Catalog No.0
2007-04-30Roche VALP2, Online TDM Valproic acid , for use with the Roche/Hitachi Cobas c 501 analyzer; Catalog
2007-04-19Roche PTH (parathyroid hormone test system) for use in conjunction with Roche cobas e 411, cobas e 6
2007-04-05Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 917 and Modular P; catalog no. 0464
2007-04-05Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 911,912, 917 and Modular P; Catalog
2007-03-16Roche COBAS Integra DIG, Digoxin Reagent for use on the COBAS INTEGRA models 400, 400 plus, 700 and
2007-02-28CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use).
2006-12-15Roche IGGT COBAS INTEGRA Immunoglobulin G (Turbidimetric); Catalog no. 20766631322. in vitro diagnos
2006-10-18CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use), 311623
2006-09-15Roche Elecsys Folate II for use on Elecsys 210 Analyzers; Catalog No. 3253678 (Roche Material No. 03
2006-07-25Roche Tina-Quant ASLO (Anti-streptolysin O) Reagent Kit; Catalog No. 1931601 (Roche Material No. 119
2006-07-21Roche/Hitachi K Electrode, a potassium electrode for use with the Roche/Hitachi models 717,747, 902,
2006-07-17Roche MagNA Pure LC Instrument Kit; Catalog no. 12236931001. An automated, general purpose instrume
2006-07-17Roche MagNA Pure LC Instrument; Catalog nos. 12236931444, 12236931692 ( Refurbished) and 12236931690
2006-07-17Roche MagNA Pure LC System (RMD); Catalog no. 03670325001. An automated, general purpose instrument
2006-07-14Roche/Hitachi K Electrode, a potassium electrode for use with the Roche/Hitachi models 717,747, 902,
2006-06-27Accu-Chek Advantage II blood glucose test strips; International Reference nos. 12030659001, 12030667
2006-06-27Accu-Chek Advantage blood glucose test strips; U.S. Reference nos. (packaged in 50s and/or 100s) 031
2006-06-27Accu-Chek Advantage Plus blood glucose test strips; International Reference no. 04735102001.
2006-06-27Accu-Chek Comfort Curve blood glucose test strips; (packaged in 10s, 50s, and/or 100s) U.S. Referenc
2006-06-27Accu-Chek Sensor Comfort Pro blood glucose test strips; International Reference nos. 03758770001, 03
2006-06-27Accu-Chek Sensor Comfort blood glucose test strips; International Reference nos. 03261956170, 032619
2006-06-27Accu-Chek Inform blood glucose test strips; International Reference nos. 04535057001, 04647696001 an
2006-06-27Accu-Chek Advantage Pro blood glucose test strips; International Reference no. 04534972001.
2006-06-22AccuData GTS Plus AccuData GTS For Blood Glucose Monitoring and Automated Data Management, contents
2006-06-22ACCU-CHEK Complete diabetes monitoring kit/ care kit/ insulin pump therapy kit, Cat. no 515; Ref. no
2006-06-22ACCU-CHEK HQ for Blood Glucose Monitoring and Automated Data Management and Communication; Contents
2006-06-22ACCU-CHEK Advantage (Consignment kit), Cat. no. 3000320; catalog no. 03000320001 with meter model no
2006-06-22ACCU-CHEK Voicemate System, Advantage Blood Glucose Meter and Voice Unit - English language version
2006-06-22ACCU-CHEK Advantage Blood Glucose Meter, Cat. No. 3332586; Ref. no. 03332586001 with meter model no.
2006-06-22ACCU-CHEK Voicemate System, Advantage Blood Glucose Meter and Voice Unit - Spanish language version
2006-06-22GTS Advantage Meter. Cat. no. 424. Ref. no. 03144780001 with meter model no. 777.
2006-06-22ACCU-CHEK Advantage Blood Glucose Meter, Cat. No. 2137500; Ref. no. 0385633001 with meter model no.
2006-06-22ACCU-CHEK Advantage (Managed Care Kit) 100- value memory with time and date, Not for Retail Sale, C
2006-06-22ACCU-CHEK Advantage Blood Glucose Meter/ Blood Glucose Monitoring System; Cat. no. 870. Ref. no. 0
2006-06-22ACCU-CHEK Comfort Curve, Cat. No. 2139634. Ref. numbers 03856348001 and 12139642001 both with mete
2006-06-22ACCU-CHEK Advantage (Conversion Kit),Cat. no. 3000338; Ref no. 03000338001 with meter model no. 2138
2006-06-22ACCU-CHEK Complete blood glucose monitor, Ref. no. 516; Catalog nos. 03266770001 and 03871983001 wit
2006-06-22AccuData GTS Plus for Blood Glucose Monitoring and Automated Data Management including GTS Plus with
2006-06-22ACCU-CHEK Comfort Curve. Cat. No. 3149030; Ref. number 0314903001 with meter model number 2138930.
2006-06-22ACCU-CHEK Advantage FPO Diabetes Monitoring Kit, Cat. no. 3271358001. Ref. no. 03271358001 with met
2006-06-22ACCU-CHEK Advantage Complete Diabetes Monitoring Kit, Cat. No. 860. Ref. no. 080086000 with meter m
2006-06-07Roche Calcium Reagent Kit for use on the Cobas MIRA Chemistry System; in vitro diagnostic; Cat. No.
2006-04-12Roche/Hitachi Glucose Hexokinase Reagent for use on the Hitachi Modular System; Catalog # 1929542 (
2006-04-04Roche MagNA Pure LC DNA Isolation Kit - Large Volume; Catalog number 03310515001.
2006-04-04Roche MagNA Pure LC Total Nucleic Acid Isolation Kit - Large Volume; Catalog number 03264793001.
2006-04-04Roche MagNA Pure LC System. An automated, general purpose instrument for isolation and purification
2006-02-10Accu-Chek Sensor Comfort blood glucose test strips; Reference numbers 03261956170, 03261964170, 0314
2006-02-10Accu-Chek Inform blood glucose test strips; Reference numbers 04535057001, 04647696001 and 045351200
2006-02-10Roche brand CEDIA Tobramycin II Reagent, Catalog # 1815385, Material # 11815385216.
2006-02-10Accu-Chek Sensor Comfort Pro blood glucose test strips; Reference numbers 0375877001, 03360652080, 0
2006-02-10Accu-Chek Comfort Curve blood glucose test strips; Reference numbers 12030420001, 12030373001, 12030
2006-02-10Accu-Chek Advantage blood glucose test strips; Reference numbers 03144917001, 03144704001, 031452630
2006-02-10Accu-Chek Advantage Plus blood glucose test strips; Reference number 04735102001 (All sold outside o
2006-02-10Accu-Chek Advantage II blood glucose test strips; Reference numbers 12030659001, 12030667001, 031378
2006-02-10Accu-Chek Advantage Pro blood glucose test strips; Reference number 04534972001 (All sold outside of
2006-01-31Roche brand Elecsys Troponin T; catalog number 2017644.
2005-12-09Roche brand Omni S2 Blood Gas Analyzer; Catalog # 03337111001.
2005-12-09Roche brand Omni S6 Blood Gas Analyzer; Catalog # 03337154001.
2005-12-09Roche brand Omni S4 Blood Gas Analyzer; Catalog # 03337138001.
2005-12-07Roche Elecsys total PSA CalSet, catalog number 11731696322.
2005-12-07Roche Elecsys total PSA, catalog number 11731262322.
2005-11-09Roche brand Accu-Chek Aviva Bonus Pack Display; Catalog number 045659066001. (Distributed within th
2005-11-09Roche brand Accu-Chek Aviva Care Kit; Catalog number 04422058170; - Canada Catalog number 0442205816
2005-11-09Roche brand Accu-Chek Aviva Care Kit; Catalog number 04528280001. (Distributed within the U.S.)
2005-11-09Roche brand Accu-Chek Aviva Pediatrics Kit; Catalog number 04593839001. (Distributed within the U.S.
2005-11-09Roche brand Accu-Chek Aviva Bonus Pack; Catalog number 04528247001. (Distributed within the U.S.)
2005-11-09Roche brand Accu-Chek Aviva Meter (mmol/L); Catalog numbers 03532313001 and 03532321001. (Distribut
2005-11-09Roche brand Accu-Chek Aviva Meter (mg/dL); Catalog number 03532356001. (Distributed outside of the
2005-11-09Roche brand Accu-Chek Aviva Meter Only Kit; Catalog number 04532279001. (Distributed within the U.S
2005-11-09Roche brand Accu-Chek Aviva Meter (mg/dL); Catalog number 03532275001. (Distributed within the U.S.)
2005-11-09Roche brand Accu-Chek Aviva Retail Distributor Pack; Catalog number 04578198001. (Distributed withi
2005-07-15Disetronic D-Tronplus Insulin Pump adapters; Ref 3000803; catalog reference number 0457243001 sold i
2005-06-07ACCU-CHEK Go Care Kit; Catalog number 04470052001. Kit includes an ACCU-CHEK Go meter.
2005-05-18ACCU-CHEK Compact Meter; catalog number 3183572.
2005-05-18ACCU-CHEK Instant Meter; Catalog numbers 914 and 924.
2005-05-18ACCU-CHEK Compact Care Kit; catalog number 3149137.
2005-05-18ACCU-CHEK Instant Care Kit; Catalog number 91490.
2005-05-03Roche Diagnostic HealthWear brand Professional System for weight management; Catalog # 04344456001.
2005-04-18Roche brand AccuData GTS/GTS Plus System Replacement Base/Module; Catalog number 3426050, material n
2005-04-18Roche brand AccuData GTS System; Catalog number 404, material number 03136833001.
2005-04-18Roche brand AccuData GTS Plus System; Catalog number 3000249, material number 03000249001.
2005-03-28Roche CoaguChek S System Controls; Catalog number 3033384, part numbers 010018501 and 04393198001.
2005-03-28Roche CoaguChek System Controls; Catalog number 7745, Part numbers 054207608 and 04393201001.
2005-03-28Roche CoaguChek System Controls (patient self testing); Catalog number 763, Part numbers 054200705 a
2005-02-15Roche ULTIMATE 3 HBA1C test kit for use with MIRA analyzers; catalog number 20755648322.
2005-02-15BioTek brand Automated Microplate Reader; model ELx800, Roche catalog number 21045059001.
2005-02-15BioTek brand Automated Microplate Reader; model ELx808, Roche catalog number 03145387001.
2005-02-15Roche ULTIMATE 5 HBA1C test kit for use with MIRA analyzers; catalog number 20755656322.
2005-02-15Roche COBAS INTEGRA HBA1c Kits for use with COBAS INTEGRA 400, 400+, 700 and 800 analyzers; catalog
2004-12-21Vital Scientific brand ISE Snap Pack for use only in the ISE Module 9130, Ref no. 3203-007, Roche pa
2004-12-21Alfa Wassermann brand REF E1-8 STARLYTE III ISE Fluid Pack for use in the STARLYTE III electrolyte a
2004-12-21Roche brand ISE SnapPak for use only in the AVL 9120/9130 Electrolyte Analyzer Assembled and distrib
2004-12-21Roche brand ISE SnapPak for use only in the AVL 9180/9181 Electrolyte Analyzer Assembled and distrib
2004-12-21Bayer brand Technicon RA/opeRA Systems ISE Fluid Pack for in vitro diagnostic use on the opeRA syste
2004-12-21Roche brand ISE SnapPak for use only in the AVL 9110/9140 Electrolyte Analyzer Assembled and distrib
2004-12-21AVL Scientific Corp. brand 9180 SnapPak Type D, BP5206, for use only in the AVL 9180 electrolyte ana
2004-12-03Roche brand Cardiac Reader.
2004-11-19ACCU-CHEK Inform meter; catalog No. 3035123.
2004-11-05MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001.
2004-08-20Roche/Hitachi ALT (ALAT/GPT) Reagent Kit for use on the Roche/Hitachi MODULAR ANALYTICS P Module; Ca
2004-08-20Roche/Hitachi AST (ASAT/GOT) Reagent Kit for use on the Roche/Hitachi MODULAR ANALYTICS P Module; Ca
2004-08-06Roche/Hitachi 747 - 100 clinical chemistry analyzer; catalog number 04009223680.
2004-08-06MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001.
2004-08-06Roche/Hitachi 747 - 200 clinical chemistry analyzer; catalog number 04009223680.
2004-08-06Roche/Hitachi Modular Analytical D Module DAT clinical chemistry analyzer; catalog number 0442933816
2004-08-06Roche/Hitachi Modular Analytical D Module clinical chemistry analyzer; catalog number 03739023001.
2004-08-06Roche/Hitachi Modular Additional D Module DAT clinical chemistry analyzer; catalog number 0442938916
2004-07-14Roche brand Reflotron GPT (ALT) 30 test strips; catalog # 745138.
2004-07-14Roche brand Reflotron GOT (AST), 30 test strips; catalog # 745120.
2004-06-30ACCU-CHEK Inform base unit; catalog no. 3035131.
2004-06-30ACCU-CHEK Inform meter; catalog No. 3035123.
2004-06-18Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of kit: 1- 2 x 17 ml phenytoin conjugate and 2-
2004-06-18Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of kit: 1- 1 x 37 ml phenytoin conjugate and 2-
2004-05-17Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panom
2004-05-17Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panom
2004-05-17Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panom
2004-05-17Disetronic brand 5 ml. glass cartridges used with the Panomat C, Panomat P, Panomat T and Panomat V
2004-05-17Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panom
2004-05-17Disetronic brand 5 ml. glass cartridges used with the Panomat C, Panomat P, Panomat T and Panomat V
2004-05-17Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panom
2004-05-05Tecan clinical workstation; 10-410 Tecan Genesis 150 back end, Roche catalog number 03585352001.
2004-05-05COBAS Gui software interface between the Cobas AMPLICOR instrument and the Tecan clinical workstatio
2004-05-05Tecan clinical workstation; 10-415 Tecan Genesis 150 front end, Roche catalog number 03585379001.
2004-05-05Tecan clinical workstation; Tecan Genesis 150/8 front end COBAS, Roche catalog number 03600530001.
2004-03-10AMPLICOR HPV Microwell Plate Analyte Specific Reagent (MWP); catalog 03579229190.
2004-03-10AMPLICOR HPV Master Mix Analyte Specific Reagent (HPV MMX), Catalog number 03582841190.
2004-03-05Tecan clinical workstation; Tecan Genesis 150 front end, Roche catalog number 03585379001.
2004-03-05Tecan clinical workstation; Tecan Genesis 150 back end, Roche catalog number 03585352001.
2004-03-05Tecan clinical workstation; Tecan Genesis 150/8 TCW front end COBAS (FEC), Roche catalog number 0360
2003-12-29Roche brand OMNI 1 Analyzer; catalog numbers GD0315 and GD0315R.
2003-12-29Roche brand OMNI 3 Analyzer; catalog numbers GD0355, GD0355R and GD035591.
2003-12-29Roche brand OMNI 6 Analyzer; catalog numbers GD0415, GD0415R and GD041591.
2003-12-29Roche brand OMNI 2 Analyzer; catalog numbers GD0335 and GD0335R.
2003-12-29Roche brand OMNI 7 Analyzer; catalog numbers GD0435 and GD0435R.
2003-12-29Roche brand OMNI 9 Analyzer; catalog numbers GD0475, GD0475R and GD047591.
2003-12-29Roche brand OMNI 4 Analyzer; catalog numbers GD0375 and GD0375R .
2003-12-29Roche brand OMNI 8 Analyzer; catalog numbers GD0455 and GD0455R.
2003-12-29Roche brand OMNI 5 Analyzer; catalog numbers GD0395 and GD0395R.
2003-12-15Roche brand OMNI 7 clinical chemistry analyzer; catalog numbers GD0435 and GD0435R.
2003-12-15Roche brand OMNI 9 clinical chemistry analyzer; catalog numbers GD0475, GD0475R and GD047591.
2003-12-15Roche brand OMNI 8 clinical chemistry analyzer; catalog numbers GD0455 and GD0455R.
2003-09-12CoaguChek brand PT Test Strips; U.S. catalog number 3116247 (professional use), 3116239 (patient sel
2003-09-02Roche/Hitachi brand lactate reagent for the quantitative determination of L-lactate in plasma, cereb
2003-07-28Disetronic Dahedi insulin infusion pump; catalog # 8500019.
2003-07-24Disetronic D-TRONplus Insulin Pump
2003-07-21Disetronic H-TRON V100 Insulin Pump; catalog # 8010030C [clear case] and 8010030 [solid-color case]
2003-07-21Disetronic H-TRONplus Insulin Pump; catalog # 8050023 [clear case], 8050064 [blue case], 8050021 [so
2003-06-26MagNA Pure LC Instrument; Catalog number 2236931.
2003-05-27MagNA Pure LC Instrument; Catalog number 2236931.
2003-05-08Roche/Hitachi Modular Analytics P clinical chemistry analyzer; Modular P. Catalog number 766-8156.
2003-04-25Elecsys Troponin T; catalog number 2017644
2003-04-25Elecsys Troponin T STAT; catalog number 2017423
2003-03-12CoaguChek Plus meter; catalog # 475729 and 12816001.
2003-03-12CoaguChek Pro DM meter; catalog # 1894048 and 1893211.
2003-02-20CoaguChek PT test strips, sold in 12 pack.
2003-02-13COBAS INTEGRA Creatinine Jaffe for use on the INTEGRA 400, 700 and 800 analyzers; system ID # 076434
2003-02-12Accu-Chek Advantage glucose test strips; part numbers 336, 556, 787 and 966.
2003-02-12Accu-Chek Comfort Curve glucose test strips; part numbers 2030420, 2030365, 2030373, 2030381, 300013
2002-12-16PO2 electrode for Roche AVL OMNI Analyzers. Catalog number BP1734.
2002-09-30Roche/Hitachi Tina-quant RF II; catalog # 3004902