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Roche Diagnostics Corp.

201 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Roche brand Accu-Chek Aviva Retail Distributor Pack; Catalog number 04578198001. (Distribu recall (Z-0420-06)Roche Diagnostics Corp.2006-01-24
Roche brand Accu-Chek Aviva Bonus Pack Display; Catalog number 045659066001. (Distributed recall (Z-0421-06)Roche Diagnostics Corp.2006-01-24
Roche brand Accu-Chek Aviva Pediatrics Kit; Catalog number 04593839001. (Distributed withi recall (Z-0422-06)Roche Diagnostics Corp.2006-01-24
Roche brand Accu-Chek Aviva Meter (mg/dL); Catalog number 03532275001. (Distributed within recall (Z-0423-06)Roche Diagnostics Corp.2006-01-24
Roche brand Accu-Chek Aviva Care Kit; Catalog number 04422058170; - Canada Catalog number recall (Z-0424-06)Roche Diagnostics Corp.2006-01-24
Roche brand Accu-Chek Aviva Meter (mg/dL); Catalog number 03532356001. (Distributed outsid recall (Z-0425-06)Roche Diagnostics Corp.2006-01-24
Roche brand Accu-Chek Aviva Meter (mmol/L); Catalog numbers 03532313001 and 03532321001. ( recall (Z-0426-06)Roche Diagnostics Corp.2006-01-24
Roche Elecsys total PSA, catalog number 11731262322. recall (Z-0381-06)Roche Diagnostics Corp.2006-01-11
Roche Elecsys total PSA CalSet, catalog number 11731696322. recall (Z-0382-06)Roche Diagnostics Corp.2006-01-11
Roche brand Omni S2 Blood Gas Analyzer; Catalog # 03337111001. recall (Z-0361-06)Roche Diagnostics Corp.2006-01-07
Roche brand Omni S4 Blood Gas Analyzer; Catalog # 03337138001. recall (Z-0362-06)Roche Diagnostics Corp.2006-01-07
Roche brand Omni S6 Blood Gas Analyzer; Catalog # 03337154001. recall (Z-0363-06)Roche Diagnostics Corp.2006-01-07
Roche CoaguChek System Controls (patient self testing); Catalog number 763, Part numbers 0 recall (Z-0098-06)Roche Diagnostics Corp.2005-10-28
Roche CoaguChek System Controls; Catalog number 7745, Part numbers 054207608 and 043932010 recall (Z-0099-06)Roche Diagnostics Corp.2005-10-28
Roche CoaguChek S System Controls; Catalog number 3033384, part numbers 010018501 and 0439 recall (Z-0100-06)Roche Diagnostics Corp.2005-10-28
ACCU-CHEK Go Care Kit; Catalog number 04470052001. Kit includes an ACCU-CHEK Go meter. recall (Z-1370-05)Roche Diagnostics Corp.2005-08-13
Roche Diagnostic HealthWear brand Professional System for weight management; Catalog # 043 recall (Z-1113-05)Roche Diagnostics Corp.2005-08-12
Disetronic D-Tronplus Insulin Pump adapters; Ref 3000803; catalog reference number 0457243 recall (Z-1105-05)Roche Diagnostics Corp.2005-08-06
ACCU-CHEK Instant Meter; Catalog numbers 914 and 924. recall (Z-0978-05)Roche Diagnostics Corp.2005-07-13
ACCU-CHEK Instant Care Kit; Catalog number 91490. recall (Z-0979-05)Roche Diagnostics Corp.2005-07-13
ACCU-CHEK Compact Meter; catalog number 3183572. recall (Z-0976-05)Roche Diagnostics Corp.2005-07-12
ACCU-CHEK Compact Care Kit; catalog number 3149137. recall (Z-0977-05)Roche Diagnostics Corp.2005-07-12
Roche brand AccuData GTS Plus System; Catalog number 3000249, material number 03000249001. recall (Z-0881-05)Roche Diagnostics Corp.2005-06-11
Roche brand AccuData GTS System; Catalog number 404, material number 03136833001. recall (Z-0882-05)Roche Diagnostics Corp.2005-06-11
Roche brand AccuData GTS/GTS Plus System Replacement Base/Module; Catalog number 3426050, recall (Z-0883-05)Roche Diagnostics Corp.2005-06-11
Roche COBAS INTEGRA HBA1c Kits for use with COBAS INTEGRA 400, 400+, 700 and 800 analyzers recall (Z-0649-05)Roche Diagnostics Corp.2005-03-23
Roche ULTIMATE 3 HBA1C test kit for use with MIRA analyzers; catalog number 20755648322. recall (Z-0650-05)Roche Diagnostics Corp.2005-03-23
Roche ULTIMATE 5 HBA1C test kit for use with MIRA analyzers; catalog number 20755656322. recall (Z-0651-05)Roche Diagnostics Corp.2005-03-23
Roche brand ISE SnapPak for use only in the AVL 9120/9130 Electrolyte Analyzer Assembled a recall (Z-0605-05)Roche Diagnostics Corp.2005-03-11
Roche brand ISE SnapPak for use only in the AVL 9180/9181 Electrolyte Analyzer Assembled a recall (Z-0606-05)Roche Diagnostics Corp.2005-03-11
Roche brand ISE SnapPak for use only in the AVL 9110/9140 Electrolyte Analyzer Assembled a recall (Z-0607-05)Roche Diagnostics Corp.2005-03-11
Bayer brand Technicon RA/opeRA Systems ISE Fluid Pack for in vitro diagnostic use on the o recall (Z-0608-05)Roche Diagnostics Corp.2005-03-11
Alfa Wassermann brand REF E1-8 STARLYTE III ISE Fluid Pack for use in the STARLYTE III ele recall (Z-0609-05)Roche Diagnostics Corp.2005-03-11
AVL Scientific Corp. brand 9180 SnapPak Type D, BP5206, for use only in the AVL 9180 elect recall (Z-0610-05)Roche Diagnostics Corp.2005-03-11
Vital Scientific brand ISE Snap Pack for use only in the ISE Module 9130, Ref no. 3203-007 recall (Z-0611-05)Roche Diagnostics Corp.2005-03-11
BioTek brand Automated Microplate Reader; model ELx800, Roche catalog number 21045059001. recall (Z-0573-05)Roche Diagnostics Corp.2005-03-08
BioTek brand Automated Microplate Reader; model ELx808, Roche catalog number 03145387001. recall (Z-0574-05)Roche Diagnostics Corp.2005-03-08
Roche brand Cardiac Reader. recall (Z-0383-05)Roche Diagnostics Corp.2005-01-06
ACCU-CHEK Inform meter; catalog No. 3035123. recall (Z-0372-05)Roche Diagnostics Corp.2004-12-28
MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001. recall (Z-0297-05)Roche Diagnostics Corp.2004-12-08
Roche/Hitachi 747 - 100 clinical chemistry analyzer; catalog number 04009223680. recall (Z-1428-04)Roche Diagnostics Corp.2004-09-02
Roche/Hitachi Modular Analytical D Module clinical chemistry analyzer; catalog number 0373 recall (Z-1429-04)Roche Diagnostics Corp.2004-09-02
Roche/Hitachi Modular Analytical D Module DAT clinical chemistry analyzer; catalog number recall (Z-1430-04)Roche Diagnostics Corp.2004-09-02
Roche/Hitachi Modular Additional D Module DAT clinical chemistry analyzer; catalog number recall (Z-1431-04)Roche Diagnostics Corp.2004-09-02
Roche/Hitachi 747 - 200 clinical chemistry analyzer; catalog number 04009223680. recall (Z-1432-04)Roche Diagnostics Corp.2004-09-02
Roche/Hitachi ALT (ALAT/GPT) Reagent Kit for use on the Roche/Hitachi MODULAR ANALYTICS P recall (Z-1434-04)Roche Diagnostics Corp.2004-09-02
Roche/Hitachi AST (ASAT/GOT) Reagent Kit for use on the Roche/Hitachi MODULAR ANALYTICS P recall (Z-1435-04)Roche Diagnostics Corp.2004-09-02
MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001. recall (Z-1371-04)Roche Diagnostics Corp.2004-08-17
Roche brand Reflotron GOT (AST), 30 test strips; catalog # 745120. recall (Z-1302-04)Roche Diagnostics Corp.2004-07-31
Roche brand Reflotron GPT (ALT) 30 test strips; catalog # 745138. recall (Z-1303-04)Roche Diagnostics Corp.2004-07-31
Roche brand OMNI 1 Analyzer; catalog numbers GD0315 and GD0315R. recall (Z-0329-04)Roche Diagnostics Corp.2004-07-20
Roche brand OMNI 2 Analyzer; catalog numbers GD0335 and GD0335R. recall (Z-0330-04)Roche Diagnostics Corp.2004-07-20
Roche brand OMNI 3 Analyzer; catalog numbers GD0355, GD0355R and GD035591. recall (Z-0331-04)Roche Diagnostics Corp.2004-07-20
Roche brand OMNI 4 Analyzer; catalog numbers GD0375 and GD0375R . recall (Z-0332-04)Roche Diagnostics Corp.2004-07-20
Roche brand OMNI 5 Analyzer; catalog numbers GD0395 and GD0395R. recall (Z-0333-04)Roche Diagnostics Corp.2004-07-20
Roche brand OMNI 6 Analyzer; catalog numbers GD0415, GD0415R and GD041591. recall (Z-0334-04)Roche Diagnostics Corp.2004-07-20
Roche brand OMNI 7 Analyzer; catalog numbers GD0435 and GD0435R. recall (Z-0335-04)Roche Diagnostics Corp.2004-07-20
Roche brand OMNI 8 Analyzer; catalog numbers GD0455 and GD0455R. recall (Z-0336-04)Roche Diagnostics Corp.2004-07-20
Roche brand OMNI 9 Analyzer; catalog numbers GD0475, GD0475R and GD047591. recall (Z-0337-04)Roche Diagnostics Corp.2004-07-20
AMPLICOR HPV Master Mix Analyte Specific Reagent (HPV MMX), Catalog number 03582841190. recall (Z-0933-04)Roche Diagnostics Corp.2004-07-20
AMPLICOR HPV Microwell Plate Analyte Specific Reagent (MWP); catalog 03579229190. recall (Z-0934-04)Roche Diagnostics Corp.2004-07-20
Tecan clinical workstation; Tecan Genesis 150 front end, Roche catalog number 03585379001. recall (Z-0996-04)Roche Diagnostics Corp.2004-07-20
Tecan clinical workstation; Tecan Genesis 150/8 TCW front end COBAS (FEC), Roche catalog n recall (Z-0997-04)Roche Diagnostics Corp.2004-07-20
Tecan clinical workstation; Tecan Genesis 150 back end, Roche catalog number 03585352001. recall (Z-0998-04)Roche Diagnostics Corp.2004-07-20
Tecan clinical workstation; 10-410 Tecan Genesis 150 back end, Roche catalog number 035853 recall (Z-0999-04)Roche Diagnostics Corp.2004-07-20
Tecan clinical workstation; 10-415 Tecan Genesis 150 front end, Roche catalog number 03585 recall (Z-1000-04)Roche Diagnostics Corp.2004-07-20
Tecan clinical workstation; Tecan Genesis 150/8 front end COBAS, Roche catalog number 0360 recall (Z-1001-04)Roche Diagnostics Corp.2004-07-20
COBAS Gui software interface between the Cobas AMPLICOR instrument and the Tecan clinical recall (Z-1021-04)Roche Diagnostics Corp.2004-07-20
ACCU-CHEK Inform meter; catalog No. 3035123. recall (Z-1060-04)Roche Diagnostics Corp.2004-07-20
ACCU-CHEK Inform base unit; catalog no. 3035131. recall (Z-1061-04)Roche Diagnostics Corp.2004-07-20
Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of kit: 1- 2 x 17 ml phenytoin conjugat recall (Z-1062-04)Roche Diagnostics Corp.2004-07-20
Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of kit: 1- 1 x 37 ml phenytoin conjugat recall (Z-1063-04)Roche Diagnostics Corp.2004-07-20
Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panoma recall (Z-1222-04)Roche Diagnostics Corp.2004-07-20
Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panoma recall (Z-1223-04)Roche Diagnostics Corp.2004-07-20
Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panoma recall (Z-1224-04)Roche Diagnostics Corp.2004-07-20
Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panoma recall (Z-1225-04)Roche Diagnostics Corp.2004-07-20
Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panoma recall (Z-1226-04)Roche Diagnostics Corp.2004-07-20
Disetronic brand 5 ml. glass cartridges used with the Panomat C, Panomat P, Panomat T and recall (Z-1227-04)Roche Diagnostics Corp.2004-07-20
Disetronic brand 5 ml. glass cartridges used with the Panomat C, Panomat P, Panomat T and recall (Z-1228-04)Roche Diagnostics Corp.2004-07-20
Roche brand OMNI 7 clinical chemistry analyzer; catalog numbers GD0435 and GD0435R. recall (Z-0326-04)Roche Diagnostics Corp.2004-01-10
Roche brand OMNI 8 clinical chemistry analyzer; catalog numbers GD0455 and GD0455R. recall (Z-0327-04)Roche Diagnostics Corp.2004-01-10
Roche brand OMNI 9 clinical chemistry analyzer; catalog numbers GD0475, GD0475R and GD0475 recall (Z-0328-04)Roche Diagnostics Corp.2004-01-10
Roche/Hitachi Modular Analytics P clinical chemistry analyzer; Modular P. Catalog number 7 recall (Z-0012-04)Roche Diagnostics Corp.2003-10-15
Roche/Hitachi brand lactate reagent for the quantitative determination of L-lactate in pla recall (Z-0028-04)Roche Diagnostics Corp.2003-10-15
CoaguChek brand PT Test Strips; U.S. catalog number 3116247 (professional use), 3116239 (p recall (Z-1293-03)Roche Diagnostics Corp.2003-10-15
Disetronic D-TRONplus Insulin Pump recall (Z-1198-03)Roche Diagnostics Corp.2003-09-23
Disetronic Dahedi insulin infusion pump; catalog # 8500019. recall (Z-1244-03)Roche Diagnostics Corp.2003-09-23
Disetronic H-TRON V100 Insulin Pump; catalog # 8010030C [clear case] and 8010030 [solid-co recall (Z-1196-03)Roche Diagnostics Corp.2003-09-17
Disetronic H-TRONplus Insulin Pump; catalog # 8050023 [clear case], 8050064 [blue case], 8 recall (Z-1197-03)Roche Diagnostics Corp.2003-09-17
MagNA Pure LC Instrument; Catalog number 2236931. recall (Z-1044-03)Roche Diagnostics Corp.2003-07-23
Roche/Hitachi Tina-quant RF II; catalog # 3004902 recall (Z-1030-03)Roche Diagnostics Corp.2003-07-19
MagNA Pure LC Instrument; Catalog number 2236931. recall (Z-1001-03)Roche Diagnostics Corp.2003-07-15
Elecsys Troponin T; catalog number 2017644 recall (Z-0870-03)Roche Diagnostics Corp.2003-05-29
Elecsys Troponin T STAT; catalog number 2017423 recall (Z-0871-03)Roche Diagnostics Corp.2003-05-29
CoaguChek Pro DM meter; catalog # 1894048 and 1893211. recall (Z-0813-03)Roche Diagnostics Corp.2003-05-14
CoaguChek Plus meter; catalog # 475729 and 12816001. recall (Z-0814-03)Roche Diagnostics Corp.2003-05-14
CoaguChek PT test strips, sold in 12 pack. recall (Z-0720-03)Roche Diagnostics Corp.2003-04-10
Accu-Chek Comfort Curve glucose test strips; part numbers 2030420, 2030365, 2030373, 20303 recall (Z-0715-03)Roche Diagnostics Corp.2003-04-09
Accu-Chek Advantage glucose test strips; part numbers 336, 556, 787 and 966. recall (Z-0716-03)Roche Diagnostics Corp.2003-04-09
COBAS INTEGRA Creatinine Jaffe for use on the INTEGRA 400, 700 and 800 analyzers; system I recall (Z-0667-03)Roche Diagnostics Corp.2003-03-21
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