Alinity hq Analyzer

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
    HPRA

11 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    List Number: 09P68‐01
  • Description du dispositif
    Analyzers, Laboratory, Hematology
  • Manufacturer
  • Modèle / numéro de série
    List Number: 0968-01 Serial Numbers: See Attachment A
  • Description du dispositif
    IVD
  • Manufacturer
  • Modèle / numéro de série
    List Number: 09P68‐01 and 09P69‐01
  • Description du dispositif
    Analyzers, Laboratory, Hematology
  • Manufacturer
  • Modèle / numéro de série
    List Number: 09P68‐01 Multiple serial numbers of the affected device are provided in the attached FSN.
  • Description du dispositif
    Analyzers, Laboratory, Clinical Chemistry/Immunoassay
  • Manufacturer
  • Modèle / numéro de série
  • Description du dispositif
    In-vitro diagnostics - haematological, histological and cytological products
  • Manufacturer
6 en plus