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Crédits
Manufacturers
Roche Diagnostics Corp.
Adresse du fabricant
Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46256-1025
Source
USFDA
150 Events
Rappel de Device Recall AMPLICOR HPV Master Mix Analyte Specific Reagent
Rappel de Device Recall AMPLICOR HPV Microwell Plate Analyte Specific Reagent
Rappel de Device Recall HTron V100
Rappel de Device Recall HTRONplus
Rappel de Device Recall Dtron
Rappel de Device Recall OMNI 7
Rappel de Device Recall OMNI 8
Rappel de Device Recall OMNI 9
Rappel de Roche brand OMNI 1 Analyzer; catalog numbers GD0315 and GD0315R.
Rappel de Roche brand OMNI 2 Analyzer; catalog numbers GD0335 and GD0335R.
Rappel de Roche brand OMNI 3 Analyzer; catalog numbers GD0355, GD0355R and GD035591.
Rappel de Roche brand OMNI 4 Analyzer; catalog numbers GD0375 and GD0375R .
Rappel de Roche brand OMNI 5 Analyzer; catalog numbers GD0395 and GD0395R.
Rappel de Roche brand OMNI 6 Analyzer; catalog numbers GD0415, GD0415R and GD041591.
Rappel de Roche brand OMNI 7 Analyzer; catalog numbers GD0435 and GD0435R.
Rappel de Roche brand OMNI 8 Analyzer; catalog numbers GD0455 and GD0455R.
Rappel de Roche brand OMNI 9 Analyzer; catalog numbers GD0475, GD0475R and GD047591.
Rappel de Device Recall Tecan Genesis
Rappel de Device Recall Tecan
Rappel de Device Recall Tecan
Rappel de 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.
Rappel de 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.
Rappel de 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.
Rappel de 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.
Rappel de 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.
Rappel de 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.
Rappel de 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.
Rappel de Tecan clinical workstation; 10-410 Tecan Genesis 150 back end, Roche catalog number 03585352001.
Rappel de Tecan clinical workstation; 10-415 Tecan Genesis 150 front end, Roche catalog number 03585379001.
Rappel de Tecan clinical workstation; Tecan Genesis 150/8 front end COBAS, Roche catalog number 03600530001.
Rappel de 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.
Rappel de 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.
Rappel de 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.
Rappel de Roche brand Reflotron GOT (AST), 30 test strips; catalog # 745120.
Rappel de Roche brand Reflotron GPT (ALT) 30 test strips; catalog # 745138.
Rappel de Roche/Hitachi ALT (ALAT/GPT) Reagent Kit for use on the Roche/Hitachi MODULAR ANALYTICS P Module; Catalog number 1877470 (11877470216).
Rappel de Roche/Hitachi AST (ASAT/GOT) Reagent Kit for use on the Roche/Hitachi MODULAR ANALYTICS P Module; Catalog number 1928511 (11928511216).
Rappel de ACCU-CHEK Inform meter; catalog No. 3035123.
Rappel de Device Recall MagNA Pure
Rappel de Roche brand Cardiac Reader.
Rappel de 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.
Rappel de Device Recall Integra
Rappel de 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.
Rappel de 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.
Rappel de 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.
Rappel de Device Recall MIRA
Rappel de BioTek brand Automated Microplate Reader; model ELx800, Roche catalog number 21045059001.
Rappel de BioTek brand Automated Microplate Reader; model ELx808, Roche catalog number 03145387001.
Rappel de Device Recall MIRA
Rappel de Alfa Wassermann brand REF E1-8 STARLYTE III ISE Fluid Pack for use in the STARLYTE III electrolyte analyzer, Roche part number 03361152001.
Rappel de AVL Scientific Corp. brand 9180 SnapPak Type D, BP5206, for use only in the AVL 9180 electrolyte analyzer, Roche part number 03112357182.
Rappel de Vital Scientific brand ISE Snap Pack for use only in the ISE Module 9130, Ref no. 3203-007, Roche part number 03522032001.
Rappel de Roche CoaguChek System Controls (patient self testing); Catalog number 763, Part numbers 054200705 and 047514003.
Rappel de Roche CoaguChek System Controls; Catalog number 7745, Part numbers 054207608 and 04393201001.
Rappel de Roche CoaguChek S System Controls; Catalog number 3033384, part numbers 010018501 and 04393198001.
Rappel de Device Recall Healthwear
Rappel de ACCU-CHEK Instant Meter; Catalog numbers 914 and 924.
Rappel de Device Recall AccuChek Go
Rappel de ACCU-CHEK Instant Care Kit; Catalog number 91490.
Rappel de Device Recall Disetronic DTron
Rappel de Device Recall AccuChek Aviva
Rappel de Device Recall AccuChek Aviva
Rappel de Device Recall AccuChek Aviva
Rappel de Device Recall AccuChek Aviva
Rappel de Device Recall AccuChek Aviva
Rappel de Device Recall AccuChek Aviva
Rappel de Device Recall AccuChek Aviva
Rappel de Device Recall AccuChek Aviva
Rappel de Device Recall AccuChek Aviva
Rappel de Device Recall AccuChek Aviva
Rappel de Device Recall OMNI
Rappel de Device Recall OMNI
Rappel de Device Recall OMNI
Rappel de Device Recall Elecsys
Rappel de Device Recall Elecsys
Rappel de Device Recall Elecsys
Rappel de Device Recall AccuChek
Rappel de Device Recall AccuChek
Rappel de Device Recall AccuChek
Rappel de Device Recall AccuChek
Rappel de Device Recall AccuChek
Rappel de Device Recall AccuChek
Rappel de Device Recall AccuChek
Rappel de Device Recall AccuChek
Rappel de Device Recall AccuChek
Rappel de Device Recall AccuChek
Rappel de Device Recall CEDIA
Rappel de Device Recall Roche
Rappel de Device Recall ACCUCHEK
Rappel de Device Recall ACCUCHEK
Rappel de Device Recall ACCUCHEK
Rappel de Device Recall ACCUCHEK
Rappel de Device Recall ACCUCHEK
Rappel de Device Recall ACCUCHEK
Rappel de Device Recall ACCUCHEK
Rappel de Device Recall ACCUCHEK
Rappel de Device Recall TinaQuant ASLO
Rappel de Device Recall Roche/Hitachi K Electrode
Rappel de Device Recall MagNa Pure
Rappel de Device Recall MagNa Pure
Rappel de Device Recall MagNa Pure
Rappel de Device Recall Roche Hitachi K electrode
Rappel de Device Recall Roche COBAS INTEGRA IGGT
Rappel de Roche/Hitachi 747 - 100 clinical chemistry analyzer; catalog number 04009223680.
Rappel de Roche/Hitachi Modular Additional D Module DAT clinical chemistry analyzer; catalog number 04429389160.
Rappel de Roche/Hitachi Modular Analytical D Module clinical chemistry analyzer; catalog number 03739023001.
Rappel de Roche/Hitachi Modular Analytical D Module DAT clinical chemistry analyzer; catalog number 04429338160.
Rappel de MagNA Pure
Rappel de Roche/Hitachi 747 - 200 clinical chemistry analyzer; catalog number 04009223680.
Rappel de AccuData
Rappel de AccuData
Rappel de AccuData
Rappel de MagNa Pure
Rappel de MagNa Pure
Rappel de MagNa Pure
Rappel de Roche/Hitachi Glucose Hexokinase Reagent
Rappel de Roche Online TDM Tobramycin
Rappel de Roche Online TDM Tobramycin
Rappel de Roche cobas 6000 analyzer (cobas c 501 and cobas e 601)
Rappel de Roche cobas 6000 analyzer (cobas c 501 and cobas e 601)
Rappel de Roche/Hitachi Preciset TDM I
Rappel de Roche/Hitachi Preciset TDM II
Rappel de Device Recall COBAS Integra DIG
Rappel de Device Recall Roche LIPC Lipase colorimetric reagent
Rappel de Device Recall Roche COBAS 6000
Rappel de Device Recall Roche Diagnostics LDL_C
Rappel de Device Recall Roche Diagnostics IRON2
Rappel de Device Recall Roche Diagnostics CREP2
Rappel de Device Recall Roche Diagnostics STFR Tinaquant, soluble trasferrin receptor
Rappel de Device Recall Roche Diagnostics HDLC3, HDLcholesterol plus 3rd generation
Rappel de Device Recall Roche Diagnostics ALBT2, Tinaquant Albumin Gen.2
Rappel de Device Recall Roche Diagnostics NAPA2
Rappel de Device Recall Roche/Hitachi Modular E Module
Rappel de Device Recall Roche/Hitachi Modular Analytics System
Rappel de Device Recall Roche/Hitachi Modular Analytics System
Rappel de Device Recall Roche/Hitachi Modular Analytics System
Rappel de Device Recall Roche/Hitachi Modular Analytics System
Rappel de Device Recall Roche COBAS c 111 Analyzer
Rappel de Device Recall Roche MagNA Pure LC Workstation
Rappel de Device Recall Roche ACCUCHEK Softclix Lancing Device
Rappel de Device Recall Roche ACCUChek Active Meter Kit
Rappel de Device Recall Roche ACCUChek Voicemate Meter
Rappel de Device Recall Roche ACCUChek Aviva Meter Kit
Rappel de Device Recall Roche Coaguchex XS Systems for Patient SelfTesting
Rappel de Device Recall Roche ACCUChek Coaguchex XS Systems for Patient SelfTesting
Rappel de Device Recall Roche ACCUCHEK Performa blood glucose test strips
Rappel de Device Recall Roche ACCUCHEK Performa blood glucose meter
Rappel de Roche Elecsys Folate II
Rappel de Coaguchek
Rappel de Roche ISE Internal Standard Gen.2
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116 dispositifs dans la base de données
Device Recall AMPLICOR HPV Master Mix Analyte Specific Reagent
Modèle / numéro de série
Lot E11927; exp. 10/04.
Distribution
Florida and Virginia.
Description du dispositif
AMPLICOR HPV Master Mix Analyte Specific Reagent (HPV MMX), Catalog number 03582841190.
Device Recall AMPLICOR HPV Microwell Plate Analyte Specific Reagent
Modèle / numéro de série
Lot E12989; exp 7/04.
Distribution
Florida and Virginia.
Description du dispositif
AMPLICOR HPV Microwell Plate Analyte Specific Reagent (MWP); catalog 03579229190.
Device Recall HTron V100
Modèle / numéro de série
All units.
Classification du dispositif
General Hospital and Personal Use Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
United States
Description du dispositif
Disetronic H-TRON V100 Insulin Pump; catalog # 8010030C [clear case] and 8010030 [solid-color case]
Device Recall HTRONplus
Modèle / numéro de série
All units.
Classification du dispositif
General Hospital and Personal Use Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
United States
Description du dispositif
Disetronic H-TRONplus Insulin Pump; catalog # 8050023 [clear case], 8050064 [blue case], 8050021 [solid-color case] and 8050071 [yellow case].
Device Recall Dtron
Modèle / numéro de série
all units.
Classification du dispositif
General Hospital and Personal Use Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
United States
Description du dispositif
Disetronic D-TRONplus Insulin Pump
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Roche Diagnostics Corp.
Adresse du fabricant
Roche Diagnostics Corp., 9115 Hague Road, Indianapolis IN 46250-0457
Source
USFDA
Roche Diagnostics Corp.
Adresse du fabricant
Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46250-0416
Source
USFDA
Language
English
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