Abbott Laboratories Singapore Pte Ltd

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21 dispositifs dans la base de données

  • Modèle / numéro de série
  • Description du dispositif
    Multigent Creatinine (Enzymatic), Sentinel CH. SpA
  • Modèle / numéro de série
  • Description du dispositif
    CP3000 w/ CTS 230V & CP3000 w/o CTS 230V, Sekisui Medical Co. LTD
  • Modèle / numéro de série
  • Description du dispositif
    Sekisui Diagnostics Acetaminophen L3K Assay, Sekisui Diagnostics P.E.I. Inc
  • Modèle / numéro de série
  • Description du dispositif
    MitraClip Clip Delivery System, Evalve LLC (DBA Abbott Vascular Inc.)
  • Modèle / numéro de série
  • Description du dispositif
    ARCHITECT Total T4 Calibrators, Abbott Ireland, Diagnostics Division
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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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