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Credits
Manufacturers
Roche Diagnostics Corp.
Manufacturer Address
Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46256-1025
Source
USFDA
150 Events
Recall of Device Recall AMPLICOR HPV Master Mix Analyte Specific Reagent
Recall of Device Recall AMPLICOR HPV Microwell Plate Analyte Specific Reagent
Recall of Device Recall HTron V100
Recall of Device Recall HTRONplus
Recall of Device Recall Dtron
Recall of Device Recall OMNI 7
Recall of Device Recall OMNI 8
Recall of Device Recall OMNI 9
Recall of Roche brand OMNI 1 Analyzer; catalog numbers GD0315 and GD0315R.
Recall of Roche brand OMNI 2 Analyzer; catalog numbers GD0335 and GD0335R.
Recall of Roche brand OMNI 3 Analyzer; catalog numbers GD0355, GD0355R and GD035591.
Recall of Roche brand OMNI 4 Analyzer; catalog numbers GD0375 and GD0375R .
Recall of Roche brand OMNI 5 Analyzer; catalog numbers GD0395 and GD0395R.
Recall of Roche brand OMNI 6 Analyzer; catalog numbers GD0415, GD0415R and GD041591.
Recall of Roche brand OMNI 7 Analyzer; catalog numbers GD0435 and GD0435R.
Recall of Roche brand OMNI 8 Analyzer; catalog numbers GD0455 and GD0455R.
Recall of Roche brand OMNI 9 Analyzer; catalog numbers GD0475, GD0475R and GD047591.
Recall of Device Recall Tecan Genesis
Recall of Device Recall Tecan
Recall of Device Recall Tecan
Recall of Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T, Panomat V and Dahedi Infusion pumps and Pen 10 insulin pens in 10 x 10 box (10 cartidges per blister pack; 10 blister packs per box; Manufactured by Disetronic Medical Systems AG, CH-3401, Burgdorf, Switzerland; catalog number 150.0157.
Recall of Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T, Panomat V and Dahedi Infusion pumps and Pen 10 insulin pens in box of 25 cartridges, 25 needles; manufactured by Disetronic Medical Systems AG, CH-3401, Burgdorf, Switzerland; catalog number 300.0419.
Recall of Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T, Panomat V and Dahedi Infusion pumps and Pen 10 insulin pens, 1 cartridge; manufactured by Disetronic Medical Systems AG, CH-3401, Burgdorf, Switzerland; catalog number 150.0042.
Recall of Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T, Panomat V and Dahedi Infusion pumps and Pen 10 insulin pens in box of 25; manufactured for Disetronic Medical Systems AG, CH-3401, Burgdorf, Switzerland; catalog number 3001061.
Recall of Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T, Panomat V and Dahedi Infusion pumps and Pen 10 insulin pens, 1 cartridge; manufactured for Disetronic Medical Systems AG. CJ-3401, Burgdorf, Switzerland; catalog number 150.0272.
Recall of Disetronic brand 5 ml. glass cartridges used with the Panomat C, Panomat P, Panomat T and Panomat V infusion pumps, box of 25; catalog number 300.0420.
Recall of Disetronic brand 5 ml. glass cartridges used with the Panomat C, Panomat P, Panomat T and Panomat V infusion pumps, 1 cartridge; catalog number 150.0051.
Recall of Tecan clinical workstation; 10-410 Tecan Genesis 150 back end, Roche catalog number 03585352001.
Recall of Tecan clinical workstation; 10-415 Tecan Genesis 150 front end, Roche catalog number 03585379001.
Recall of Tecan clinical workstation; Tecan Genesis 150/8 front end COBAS, Roche catalog number 03600530001.
Recall of COBAS Gui software interface between the Cobas AMPLICOR instrument and the Tecan clinical workstation (Tecan Genesis 150/8 front end COBAS), Roche catalog number 04498984001.
Recall of Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of kit: 1- 2 x 17 ml phenytoin conjugate and 2- 2 x 18 ml anti-phenytoin antibody (mouse monoclonal); latex microparticle. Product 03800458190.
Recall of Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of kit: 1- 1 x 37 ml phenytoin conjugate and 2- 1 x 38 ml anti-phenytoin antibody (mouse monoclonal); latex microparticle. Product 03516989190.
Recall of Roche brand Reflotron GOT (AST), 30 test strips; catalog # 745120.
Recall of Roche brand Reflotron GPT (ALT) 30 test strips; catalog # 745138.
Recall of Roche/Hitachi ALT (ALAT/GPT) Reagent Kit for use on the Roche/Hitachi MODULAR ANALYTICS P Module; Catalog number 1877470 (11877470216).
Recall of Roche/Hitachi AST (ASAT/GOT) Reagent Kit for use on the Roche/Hitachi MODULAR ANALYTICS P Module; Catalog number 1928511 (11928511216).
Recall of ACCU-CHEK Inform meter; catalog No. 3035123.
Recall of Device Recall MagNA Pure
Recall of Roche brand Cardiac Reader.
Recall of Roche brand ISE SnapPak for use only in the AVL 9120/9130 Electrolyte Analyzer Assembled and distributed by Roche Diagnostics Corp., Indpls., IN; Ref/No. 03112276180; Part number BP5016.
Recall of Device Recall Integra
Recall of Roche brand ISE SnapPak for use only in the AVL 9180/9181 Electrolyte Analyzer Assembled and distributed by Roche Diagnostics Corp., Indpls., IN.; Ref/No. 03112349180, Part number BP5186.
Recall of Roche brand ISE SnapPak for use only in the AVL 9110/9140 Electrolyte Analyzer Assembled and distributed by Roche Diagnostics Corp., Indpls., IN.; Ref/No. 03112314018, Part number BP5032.
Recall of Bayer brand Technicon RA/opeRA Systems ISE Fluid Pack for in vitro diagnostic use on the opeRA system only, Manufacturer part number T01-3606-01, Mfd for Bayer Corporation, 511 Benedict Ave, Tarrytown, NY., Roche part number 03361322001.
Recall of Device Recall MIRA
Recall of BioTek brand Automated Microplate Reader; model ELx800, Roche catalog number 21045059001.
Recall of BioTek brand Automated Microplate Reader; model ELx808, Roche catalog number 03145387001.
Recall of Device Recall MIRA
Recall of Alfa Wassermann brand REF E1-8 STARLYTE III ISE Fluid Pack for use in the STARLYTE III electrolyte analyzer, Roche part number 03361152001.
Recall of AVL Scientific Corp. brand 9180 SnapPak Type D, BP5206, for use only in the AVL 9180 electrolyte analyzer, Roche part number 03112357182.
Recall of Vital Scientific brand ISE Snap Pack for use only in the ISE Module 9130, Ref no. 3203-007, Roche part number 03522032001.
Recall of Roche CoaguChek System Controls (patient self testing); Catalog number 763, Part numbers 054200705 and 047514003.
Recall of Roche CoaguChek System Controls; Catalog number 7745, Part numbers 054207608 and 04393201001.
Recall of Roche CoaguChek S System Controls; Catalog number 3033384, part numbers 010018501 and 04393198001.
Recall of Device Recall Healthwear
Recall of ACCU-CHEK Instant Meter; Catalog numbers 914 and 924.
Recall of Device Recall AccuChek Go
Recall of ACCU-CHEK Instant Care Kit; Catalog number 91490.
Recall of Device Recall Disetronic DTron
Recall of Device Recall AccuChek Aviva
Recall of Device Recall AccuChek Aviva
Recall of Device Recall AccuChek Aviva
Recall of Device Recall AccuChek Aviva
Recall of Device Recall AccuChek Aviva
Recall of Device Recall AccuChek Aviva
Recall of Device Recall AccuChek Aviva
Recall of Device Recall AccuChek Aviva
Recall of Device Recall AccuChek Aviva
Recall of Device Recall AccuChek Aviva
Recall of Device Recall OMNI
Recall of Device Recall OMNI
Recall of Device Recall OMNI
Recall of Device Recall Elecsys
Recall of Device Recall Elecsys
Recall of Device Recall Elecsys
Recall of Device Recall AccuChek
Recall of Device Recall AccuChek
Recall of Device Recall AccuChek
Recall of Device Recall AccuChek
Recall of Device Recall AccuChek
Recall of Device Recall AccuChek
Recall of Device Recall AccuChek
Recall of Device Recall AccuChek
Recall of Device Recall AccuChek
Recall of Device Recall AccuChek
Recall of Device Recall CEDIA
Recall of Device Recall Roche
Recall of Device Recall ACCUCHEK
Recall of Device Recall ACCUCHEK
Recall of Device Recall ACCUCHEK
Recall of Device Recall ACCUCHEK
Recall of Device Recall ACCUCHEK
Recall of Device Recall ACCUCHEK
Recall of Device Recall ACCUCHEK
Recall of Device Recall ACCUCHEK
Recall of Device Recall TinaQuant ASLO
Recall of Device Recall Roche/Hitachi K Electrode
Recall of Device Recall MagNa Pure
Recall of Device Recall MagNa Pure
Recall of Device Recall MagNa Pure
Recall of Device Recall Roche Hitachi K electrode
Recall of Device Recall Roche COBAS INTEGRA IGGT
Recall of Roche/Hitachi 747 - 100 clinical chemistry analyzer; catalog number 04009223680.
Recall of Roche/Hitachi Modular Additional D Module DAT clinical chemistry analyzer; catalog number 04429389160.
Recall of Roche/Hitachi Modular Analytical D Module clinical chemistry analyzer; catalog number 03739023001.
Recall of Roche/Hitachi Modular Analytical D Module DAT clinical chemistry analyzer; catalog number 04429338160.
Recall of MagNA Pure
Recall of Roche/Hitachi 747 - 200 clinical chemistry analyzer; catalog number 04009223680.
Recall of AccuData
Recall of AccuData
Recall of AccuData
Recall of MagNa Pure
Recall of MagNa Pure
Recall of MagNa Pure
Recall of Roche/Hitachi Glucose Hexokinase Reagent
Recall of Roche Online TDM Tobramycin
Recall of Roche Online TDM Tobramycin
Recall of Roche cobas 6000 analyzer (cobas c 501 and cobas e 601)
Recall of Roche cobas 6000 analyzer (cobas c 501 and cobas e 601)
Recall of Roche/Hitachi Preciset TDM I
Recall of Roche/Hitachi Preciset TDM II
Recall of Device Recall COBAS Integra DIG
Recall of Device Recall Roche LIPC Lipase colorimetric reagent
Recall of Device Recall Roche COBAS 6000
Recall of Device Recall Roche Diagnostics LDL_C
Recall of Device Recall Roche Diagnostics IRON2
Recall of Device Recall Roche Diagnostics CREP2
Recall of Device Recall Roche Diagnostics STFR Tinaquant, soluble trasferrin receptor
Recall of Device Recall Roche Diagnostics HDLC3, HDLcholesterol plus 3rd generation
Recall of Device Recall Roche Diagnostics ALBT2, Tinaquant Albumin Gen.2
Recall of Device Recall Roche Diagnostics NAPA2
Recall of Device Recall Roche/Hitachi Modular E Module
Recall of Device Recall Roche/Hitachi Modular Analytics System
Recall of Device Recall Roche/Hitachi Modular Analytics System
Recall of Device Recall Roche/Hitachi Modular Analytics System
Recall of Device Recall Roche/Hitachi Modular Analytics System
Recall of Device Recall Roche COBAS c 111 Analyzer
Recall of Device Recall Roche MagNA Pure LC Workstation
Recall of Device Recall Roche ACCUCHEK Softclix Lancing Device
Recall of Device Recall Roche ACCUChek Active Meter Kit
Recall of Device Recall Roche ACCUChek Voicemate Meter
Recall of Device Recall Roche ACCUChek Aviva Meter Kit
Recall of Device Recall Roche Coaguchex XS Systems for Patient SelfTesting
Recall of Device Recall Roche ACCUChek Coaguchex XS Systems for Patient SelfTesting
Recall of Device Recall Roche ACCUCHEK Performa blood glucose test strips
Recall of Device Recall Roche ACCUCHEK Performa blood glucose meter
Recall of Roche Elecsys Folate II
Recall of Coaguchek
Recall of Roche ISE Internal Standard Gen.2
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116 devices in the database
Device Recall AMPLICOR HPV Master Mix Analyte Specific Reagent
Model / Serial
Lot E11927; exp. 10/04.
Distribution
Florida and Virginia.
Product Description
AMPLICOR HPV Master Mix Analyte Specific Reagent (HPV MMX), Catalog number 03582841190.
Device Recall AMPLICOR HPV Microwell Plate Analyte Specific Reagent
Model / Serial
Lot E12989; exp 7/04.
Distribution
Florida and Virginia.
Product Description
AMPLICOR HPV Microwell Plate Analyte Specific Reagent (MWP); catalog 03579229190.
Device Recall HTron V100
Model / Serial
All units.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
United States
Product Description
Disetronic H-TRON V100 Insulin Pump; catalog # 8010030C [clear case] and 8010030 [solid-color case]
Device Recall HTRONplus
Model / Serial
All units.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
United States
Product Description
Disetronic H-TRONplus Insulin Pump; catalog # 8050023 [clear case], 8050064 [blue case], 8050021 [solid-color case] and 8050071 [yellow case].
Device Recall Dtron
Model / Serial
all units.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
United States
Product Description
Disetronic D-TRONplus Insulin Pump
111 more
2 manufacturers with a similar name
Learn more about the data
here
Roche Diagnostics Corp.
Manufacturer Address
Roche Diagnostics Corp., 9115 Hague Road, Indianapolis IN 46250-0457
Source
USFDA
Roche Diagnostics Corp.
Manufacturer Address
Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46250-0416
Source
USFDA
Language
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