Alere HIV Combo

Fabricant

  • 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.
  • Source
    DMA

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  • Modèle / numéro de série
    Model: , Affected: 20 Tests Kits catalogue number 7D2846, Lot number 80671K100C
  • Manufacturer
  • Modèle / numéro de série
  • Manufacturer
    N/A
  • Modèle / numéro de série
    Alere HIV Combo 78169K100 7D2842 7D2843 7D2846 7D2847 7D2843SET 7D2843SET 78169K100E 78169K100A 78169K100C 78169K100B 78169K100R 78169K100S 79290K100 7D2843SET 79290K100R 79291K100 7D2843SET 79291K100R 79292K100 7D2843SET 79292K100R 79293K100 7D2842 7D2843 7D2843 7D2843SET 79293K100C 79293K100A 79293K100B 79293K100R AlertJ
  • Manufacturer
  • Modèle / numéro de série
    Catalog Number: 7D2846, 7D2847 Batch Number: Catalog number: 7D2846 78169K100C, 80671K100C, 81502K100C Catalog Number; 7D2847 78169K100B, 80671K100A
  • Description du dispositif
    Diagnostic medical devices in vitro
  • Manufacturer
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