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  • Dispositivo 98
  • Fabricante 6
  • Evento 124969
  • Implante 0
Immucor MATCH IT! DNA Software version 3.29.0 (released 30 Jan 2018) for use with Allele Database...
  • Modelo / Serial
    Immucor MATCH IT! DNA Software version 3.29.0 (released 30 Jan 2018) for use with Allele Database used with LIFECODES HLA-B SSO Typing Kits. In vitro diagnostic medical devices.LIFECODES HLA-B SSO Typing Kit Affected Lots: 01117A (exp 30/11/2018) and 06036A (exp 31/05/2018)Typing Kit Catalogue Numbers: TL628915 and TL628915sARTG Numbers: 257272 , 217871
  • Manufacturer
    Abacus dx Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de Immucor MATCH IT! DNA Software version 3.29.0 (released 30 Jan 2018) for use with Allele Database used with LIFECODES HLA-B SSO Typing Kits. In vitro diagnostic medical devices.
Lifecodes HLA-DRB1 SSO Typing Kit and HLA-DQA1/B1 Typing Kit. An in vitro diagnostic medical devi...
  • Modelo / Serial
    Lifecodes HLA-DRB1 SSO Typing Kit and HLA-DQA1/B1 Typing Kit. An in vitro diagnostic medical device (IVD)HLA-DRB1 SSO Typing KitSupplier Code: 628923Lot Numbers: TL628923 and TL628923sLot Numbers: 04226A and 11125AHLA-DQA1/B1 SSO Typing Kit Supplier Code: 628930Lot Numbers: TL628930, TL628930s and TL628930pLot Numbers: 3004970, 06306A and 10205AARTG Numbers: 217874 and 217873
  • Manufacturer
    Diagnostic Solutions Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de Lifecodes HLA-DRB1 SSO Typing Kit and HLA-DQA1/B1 Typing Kit. An in vitro diagnostic medical device (IVD)
Cortisol Saliva ELISA. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Cortisol Saliva ELISA. An in vitro diagnostic medical device (IVD)Catalogue Number: RE52611Lot Numbers: ECO142, ECO143Expiry Dates: ECO142: 2018-02-28; ECO143: 2018-12-31ARTG Number: 210636 (Abacus ALS - Clinical chemistry hormone IVDs)
  • Manufacturer
    Abacus ALS Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de Cortisol Saliva ELISA. An in vitro diagnostic medical device (IVD)
Phadia AB Product EliA anti-TSH-R WellAn In Vitro Medical Device
  • Modelo / Serial
    Phadia AB Product EliA anti-TSH-R WellAn In Vitro Medical DeviceLot Number: 0014.Abacus ALS part number: PU14563901, Manufacturers part number: 14-5639-01ARTG Number: 229585 (Abacus ALS Pty Ltd - Clinical chemistry autoimmune IVDs)
  • Manufacturer
    Abacus ALS Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de Phadia AB Product EliA anti-TSH-R WellAn In Vitro Medical Device
Phadia ImmunoCAP Allergen c5, Ampicilloyl and ImmunoCAP Allergen c6, AmoxicilloylAn in vitro medi...
  • Modelo / Serial
    Phadia ImmunoCAP Allergen c5, Ampicilloyl and ImmunoCAP Allergen c6, AmoxicilloylAn in vitro medical deviceMaterial Numbers: 14-4450-01 and 14-4451-01Multiple Affected Lot NumbersARTG: 186054
  • Manufacturer
    Abacus ALS Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de Phadia ImmunoCAP Allergen c5, Ampicilloyl and ImmunoCAP Allergen c6, AmoxicilloylAn in vitro medical device
Phadia Prime with software up to and including version 2.1.4 . An in vitro diagnostic device (IVD...
  • Modelo / Serial
    Phadia Prime with software up to and including version 2.1.4 . An in vitro diagnostic device (IVD)With Phadia 250, Phadia 2500E/EE and Phadia 5000E/E+E running EliA testsARTG Number: 229542
  • Manufacturer
    Abacus ALS Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de Phadia Prime with software up to and including version 2.1.4 . An in vitro diagnostic device (IVD) With Phadia 250, Phadia 2500E/EE and Phadia 5000E/E+E running EliA tests
RE51021 / MuSK-Ab ELISA
  • Modelo / Serial
    RE51021 / MuSK-Ab ELISA Lot EMU124ARTG number: 210637
  • Manufacturer
    Abacus ALS Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de RE51021 / MuSK-Ab ELISA
Phadia 1000 Instrument. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Phadia 1000 Instrument. An in vitro diagnostic medical device (IVD)Article Number: 12-3800-01All instrument software (ISW) versionsAll Lot/Serial NumbersARTG Number: 192561
  • Manufacturer
    Abacus ALS Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de Phadia 1000 Instrument. An in vitro diagnostic medical device (IVD)
ImmunoCAP Allergen f205, Herring. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    ImmunoCAP Allergen f205, Herring. An in vitro diagnostic medical device (IVD)Product Number: 14-4837-01Lot Number: 999G5ARTG Number: 186054
  • Manufacturer
    Abacus ALS Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de ImmunoCAP Allergen f205, Herring. An in vitro diagnostic medical device (IVD)
MIA FORA NGS FLEX 11 HLA Typing Kit. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    MIA FORA NGS FLEX 11 HLA Typing Kit. An in vitro diagnostic medical device (IVD). Product Number:TL-SR-800-10433-24Lot Number: 18-299-11-C ARTG Number: 288368Abacus dx - Multiple human leukocyte antigens (HLA) typing IVDs
  • Manufacturer
    Abacus dx Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de MIA FORA NGS FLEX 11 HLA Typing Kit. An in vitro diagnostic medical device (IVD).
MIA FORA NGS HLA Server and Software versions 3.0 and 3.1. An in vitro diagnostic medical device ...
  • Modelo / Serial
    MIA FORA NGS HLA Server and Software versions 3.0 and 3.1. An in vitro diagnostic medical device (IVD)MIA FORA NGS HLA Server, Linux SR-790-00017 or Windows SR-790-00020MIA FORA NGS Software, Linux SR-850-00043, Windows SR-850-00062 or Registry SR-790-00068ARTG Number: 288607(Abacus dx Pty Ltd - Interpretive software IVDs)
  • Manufacturer
    Abacus dx Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de MIA FORA NGS HLA Server and Software versions 3.0 and 3.1. An in vitro diagnostic medical device (IVD)
EliA Intrinsic Factor Well. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    EliA Intrinsic Factor Well. An in vitro diagnostic medical device (IVD)Catalogue Number: PU14566801Lot number: 0015Expiry date: 31/01/2019ARTG: 229585Abacus dx - Clinical chemistry autoimmune IVDs
  • Manufacturer
    Abacus dx Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de EliA Intrinsic Factor Well. An in vitro diagnostic medical device (IVD)
MIA FORA NGS HLA FLEX 11 KIT (24 tests). An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    MIA FORA NGS HLA FLEX 11 KIT (24 tests). An in vitro diagnostic medical device (IVD) Lot Number: 18-107-11-CARTG Number: 288368
  • Manufacturer
    Diagnostic Solutions Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de MIA FORA NGS HLA FLEX 11 KIT (24 tests). An in vitro diagnostic medical device (IVD)
MIA FORA NGS Software v3.27.0. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    MIA FORA NGS Software v3.27.0. An in vitro diagnostic medical device (IVD)ARTG Number: 288607
  • Manufacturer
    Diagnostic Solutions Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de MIA FORA NGS Software v3.27.0. An in vitro diagnostic medical device (IVD)
RAPTOR GRASPING DEVICE
  • Modelo / Serial
    Model Catalog: 00711177 (Lot serial: NA)
  • Descripción del producto
    RAPTOR GRASPING DEVICE
  • Manufacturer
    VANTAGE ENDOSCOPY INC.
  • 1 Event
    • Retiro De Equipo (Recall) de RAPTOR GRASPING DEVICE
SERIES 200 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - VIDEO MODULES
  • Modelo / Serial
    Model Catalog: EPX-2500 (Lot serial: 202B1230408E or earlier)
  • Descripción del producto
    SERIES 200 ELECTRONIC VIDEO ENDOSCOPE SYSTEM
  • Manufacturer
    VANTAGE ENDOSCOPY INC.
  • 1 Event
    • Retiro De Equipo (Recall) de SERIES 200 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - VIDEO MODULES
SERIES 400 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - DUODENOSCOPE
  • Modelo / Serial
    Model Catalog: ED-530XT (Lot serial: all)
  • Descripción del producto
    Fujifilm Duodenoscope
  • Manufacturer
    VANTAGE ENDOSCOPY INC.
  • 1 Event
    • Retiro De Equipo (Recall) de SERIES 400 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - DUODENOSCOPE
VARICELLA ZOSTER VIRUS IGG KIT
  • Modelo / Serial
    Model Catalog: 2325601 (Lot serial: 568); Model Catalog: 2325600 (Lot serial: 568); Model Catalog: 2325601 (Lot serial: 567); Model Catalog: 2325600 (Lot serial: 567); Model Catalog: 2325601 (Lot serial: 566); Model Catalog: 2325600 (Lot serial: 566)
  • Manufacturer
    SOMAGEN DIAGNOSTICS INC.
  • 1 Event
    • Retiro De Equipo (Recall) de VARICELLA ZOSTER VIRUS IGG KIT
CALIBRATION VERIFICATION ASSESSMENT (CVA)
  • Modelo / Serial
    Model Catalog: (Lot serial: 8147)
  • Descripción del producto
    Calibration Verification Assessment
  • Manufacturer
    SOMAGEN DIAGNOSTICS INC.
  • 1 Event
    • Retiro De Equipo (Recall) de CALIBRATION VERIFICATION ASSESSMENT (CVA)
TRINICLOT APTT HS REAGENT
  • Modelo / Serial
    Model Catalog: T1204 (Lot serial: R324001)
  • Descripción del producto
    TRINICLOT APTT HS PRODUCT CODE T1204
  • Manufacturer
    SOMAGEN DIAGNOSTICS INC.
  • 1 Event
    • Retiro De Equipo (Recall) de TRINICLOT APTT HS REAGENT
TRIAGE TOX DRUG SCREEN (8 PANEL)
  • Modelo / Serial
    Model Catalog: 94400 (Lot serial: ALL LOT NUMBERS); Model Catalog: 94400 (Lot serial: W46854B)
  • Descripción del producto
    TRIAGE TOX DRUG SCREEN
  • Manufacturer
    SOMAGEN DIAGNOSTICS INC.
  • 1 Event
    • Retiro De Equipo (Recall) de TRIAGE TOX DRUG SCREEN (8 PANEL)
PROFILE-V MEDTOXSCAN - AMP/BAR/BZO/COC/MAMP/MTD/OPI/OXY/PCP/PPX/TCA/THC
  • Modelo / Serial
    Model Catalog: 604018 (Lot serial: 6868); Model Catalog: 604018 (Lot serial: 6864); Model Catalog: 604018 (Lot serial: 6901); Model Catalog: 604018 (Lot serial: 6902); Model Catalog: 604018 (Lot serial: 6831)
  • Descripción del producto
    Profile-V 12-MEDTOXScan
  • Manufacturer
    SOMAGEN DIAGNOSTICS INC.
  • 1 Event
    • Retiro De Equipo (Recall) de PROFILE-V MEDTOXSCAN - AMP/BAR/BZO/COC/MAMP/MTD/OPI/OXY/PCP/PPX/TCA/THC
CAPTIA EBV VCA IGM
  • Modelo / Serial
    Model Catalog: 2325760 (Lot serial: 084)
  • Descripción del producto
    CAPTIA EBV VCA IGM
  • Manufacturer
    SOMAGEN DIAGNOSTICS INC.
  • 1 Event
    • Retiro De Equipo (Recall) de CAPTIA EBV VCA IGM
MIDA AUTO-DIMER
  • Modelo / Serial
    Model Catalog: T3103 (Lot serial: 113300); Model Catalog: T3103 (Lot serial: 113301)
  • Descripción del producto
    MDA Auto Dimer
  • Manufacturer
    SOMAGEN DIAGNOSTICS INC.
  • 1 Event
    • Retiro De Equipo (Recall) de MIDA AUTO-DIMER
SERIES 200 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - GASTROSCOPE
  • Modelo / Serial
    Model Catalog: ALL (Lot serial: ALL)
  • Descripción del producto
    SERIES 200 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - GASTROSCOPE;SIGMOIDSCOPE;COLONOSCOPE EC;SERIES 400 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - BRONCHOSCOPE;DOUBLE BALLOON METHOD ELECTRONIC ENTEROSCOPY SYSTEM - ENTEROSCOPE;SERIES 200 ELECTRONIC VIDEO ENDOSCOPE SYST
  • Manufacturer
    VANTAGE ENDOSCOPY INC.
  • 1 Event
    • Retiro De Equipo (Recall) de SERIES 200 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - GASTROSCOPE
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Los dispositivos médicos ayudan con el diagnóstico, la prevención y el tratamiento de muchas lesiones y enfermedades. A través de la International Medical Devices Database no estamos sugiriendo que compañías u otras entidades mencionadas en la base de datos hayan sido parte de una conducta ilegal o hayan actuado de manera impropia. Un mismo dispositivo médico puede tener distintos nombres en diferentes países. Esta base de datos no busca proporcionar asesoría médica. Los pacientes deben consultar con sus médicos para determinar si la data contiene información relevante y si la misma tiene implicaciones médicas para ellos.

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