Inverness Medical Innovations Australia Pty Ltd T/A Alere

22 dispositifs dans la base de données

  • Modèle / numéro de série
    Alere Afinion ACR Control. An in vitro diagnostic medical device (IVD)Catalogue Number: Af1116046Lot Numbers: 10193874, 10195060ARTG: 204476(Inverness Medical Innovations Australia T/A Alere - Clinical chemistry substrate IVDs)
  • Modèle / numéro de série
    Alere HIV Combo. An in vitro diagnostic medical device (IVD)Catalogue Number: 7D2846Lot Number: 80671K100CPack Size: 20 TestsCatalogue Number: 7D2847Lot Number: 78169K100BPack Size: 100 TestsARTG Number: 276049
  • Modèle / numéro de série
    Alere INRatio / INRatio 2 PT/INR Monitoring System. An in vitro diagnostic medical device (IVD)INRatio Prothrombin Time PT Monitoring SystemProduct Code: HS0100267INRatio 2 Professional Testing KitProduct Code: HS0200431INRatio 2 Home Monitoring KitProduct Code: HS0200433, HS0200433SJM, HS200433SJMKINRatio PT/INR Test StripsProduct Codes: HS0100071, HS0100139INRatio 2 PT/INR Test Strips Heparin-InsensitiveProduct Codes: HS99007G1, HS99008G1ARTG Number: 214252
  • Classification du dispositif
  • Modèle / numéro de série
    Captia Malaria EIA Catalogue Number: 2622471 Lot Number: 005
  • Modèle / numéro de série
    Alere Actim Partus. An in vitro diagnostic medical device (IVD).Catalogue Numbers: 31930ETAL, 31931ETAL, 31931ETACMultiple batch numbers affectedARTG Number: 202704
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  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
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