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
Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T, Pano...
Jul 20, 2004
· Device
Terminated
Tecan clinical workstation; Tecan Genesis 150/8 front end COBAS, Roche catalog number 03600530001.
Jul 20, 2004
· Device
Terminated
Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T, Pano...
Jul 20, 2004
· Device
Terminated
Tecan clinical workstation; Tecan Genesis 150 back end, Roche catalog number 03585352001.
Jul 20, 2004
· Device
Terminated
Tecan clinical workstation; Tecan Genesis 150 front end, Roche catalog number 03585379001.
Jul 20, 2004
· Device
Terminated
Disetronic brand 5 ml. glass cartridges used with the Panomat C, Panomat P, Panomat T and Panomat V infusion p...
Jul 20, 2004
· Device
Terminated
ACCU-CHEK Inform meter; catalog No. 3035123.
Jul 20, 2004
· Device
Terminated
Roche brand OMNI 2 Analyzer; catalog numbers GD0335 and GD0335R.
Jul 20, 2004
· Device
Terminated
Roche brand OMNI 5 Analyzer; catalog numbers GD0395 and GD0395R.
Jul 20, 2004
· Device
Terminated
Roche brand OMNI 3 Analyzer; catalog numbers GD0355, GD0355R and GD035591.
Jul 20, 2004
· Device
Terminated
Roche brand OMNI 6 Analyzer; catalog numbers GD0415, GD0415R and GD041591.
Jul 20, 2004
· Device
Terminated
Tecan clinical workstation; 10-410 Tecan Genesis 150 back end, Roche catalog number 03585352001.
Jul 20, 2004
· Device
Terminated
Roche brand OMNI 7 Analyzer; catalog numbers GD0435 and GD0435R.
Jul 20, 2004
· Device
Terminated
AMPLICOR HPV Microwell Plate Analyte Specific Reagent (MWP); catalog 03579229190.
Jul 20, 2004
· Device
Terminated
Tecan clinical workstation; Tecan Genesis 150/8 TCW front end COBAS (FEC), Roche catalog number 0360053001.
Jul 20, 2004
· Device
Terminated
ACCU-CHEK Inform base unit; catalog no. 3035131.
Jul 20, 2004
· Device
Terminated
Roche brand OMNI 4 Analyzer; catalog numbers GD0375 and GD0375R .
Jul 20, 2004
· Device
Terminated
Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of kit: 1- 2 x 17 ml phenytoin conjugate and 2- 2 x 18 ml...
Jul 20, 2004
· Device
Terminated
AMPLICOR HPV Master Mix Analyte Specific Reagent (HPV MMX), Catalog number 03582841190.
Jul 20, 2004
· Device
Terminated
Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T, Pano...
Jul 20, 2004
· Device
Terminated
Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T, Pano...
Jul 20, 2004
· Device
Terminated
Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of kit: 1- 1 x 37 ml phenytoin conjugate and 2- 1 x 38 ml...
Jul 20, 2004
· Device
Terminated
Disetronic brand 5 ml. glass cartridges used with the Panomat C, Panomat P, Panomat T and Panomat V infusion p...
Jul 20, 2004
· Device
Terminated
Roche brand OMNI 9 Analyzer; catalog numbers GD0475, GD0475R and GD047591.
Jul 20, 2004
· Device
Terminated
COBAS Gui software interface between the Cobas AMPLICOR instrument and the Tecan clinical workstation (Tecan G...
Jul 20, 2004
· Device
Terminated
Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T, Pano...
Jul 20, 2004
· Device
Terminated
Roche brand OMNI 8 Analyzer; catalog numbers GD0455 and GD0455R.
Jul 20, 2004
· Device
Terminated
Tecan clinical workstation; 10-415 Tecan Genesis 150 front end, Roche catalog number 03585379001.
Jul 20, 2004
· Device
Terminated
Roche brand OMNI 1 Analyzer; catalog numbers GD0315 and GD0315R.
Jul 20, 2004
· Device
Terminated
Roche brand OMNI 9 clinical chemistry analyzer; catalog numbers GD0475, GD0475R and GD047591.
Jan 10, 2004
· Device
Terminated
Roche brand OMNI 7 clinical chemistry analyzer; catalog numbers GD0435 and GD0435R.
Jan 10, 2004
· Device
Terminated
Roche brand OMNI 8 clinical chemistry analyzer; catalog numbers GD0455 and GD0455R.
Jan 10, 2004
· Device
Terminated
Roche/Hitachi Modular Analytics P clinical chemistry analyzer; Modular P. Catalog number 766-8156.
Oct 15, 2003
· Device
Terminated
CoaguChek brand PT Test Strips; U.S. catalog number 3116247 (professional use), 3116239 (patient self test), e...
Oct 15, 2003
· Device
Terminated
Roche/Hitachi brand lactate reagent for the quantitative determination of L-lactate in plasma, cerebrospinal f...
Oct 15, 2003
· Device
Terminated
Disetronic Dahedi insulin infusion pump; catalog # 8500019.
Sep 23, 2003
· Device
Terminated
Disetronic D-TRONplus Insulin Pump
Sep 23, 2003
· Device
Terminated
Disetronic H-TRON V100 Insulin Pump; catalog # 8010030C [clear case] and 8010030 [solid-color case]
Sep 17, 2003
· Device
Terminated
Disetronic H-TRONplus Insulin Pump; catalog # 8050023 [clear case], 8050064 [blue case], 8050021 [solid-color...
Sep 17, 2003
· Device
Terminated
MagNA Pure LC Instrument; Catalog number 2236931.
Jul 23, 2003
· Device
Terminated
Roche/Hitachi Tina-quant RF II; catalog # 3004902
Jul 19, 2003
· Device
Terminated
MagNA Pure LC Instrument; Catalog number 2236931.
Jul 15, 2003
· Device
Terminated
Elecsys Troponin T STAT; catalog number 2017423
May 29, 2003
· Device
Terminated
Elecsys Troponin T; catalog number 2017644
May 29, 2003
· Device
Terminated
CoaguChek Pro DM meter; catalog # 1894048 and 1893211.
May 14, 2003
· Device
Terminated
CoaguChek Plus meter; catalog # 475729 and 12816001.
May 14, 2003
· Device
Terminated
CoaguChek PT test strips, sold in 12 pack.
Apr 10, 2003
· Device
Terminated
Accu-Chek Advantage glucose test strips; part numbers 336, 556, 787 and 966.
Apr 9, 2003
· Device
Terminated
Accu-Chek Comfort Curve glucose test strips; part numbers 2030420, 2030365, 2030373, 2030381, 3000133 and 3000...
Apr 9, 2003
· Device
Terminated
COBAS INTEGRA Creatinine Jaffe for use on the INTEGRA 400, 700 and 800 analyzers; system ID # 0764345, catalog...
Mar 21, 2003
· Device
Terminated