Alinity hq Analyzer

Fabricante

  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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
    HSAHSA

11 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    List Number: 09P68‐01
  • Descripción del producto
    Analyzers, Laboratory, Hematology
  • Manufacturer
  • Modelo / Serial
    List Number: 09P68‐01 and 09P69‐01
  • Descripción del producto
    Analyzers, Laboratory, Hematology
  • Manufacturer
  • Modelo / Serial
    List Number: 0968-01 Serial Numbers: See Attachment A
  • Descripción del producto
    IVD
  • Manufacturer
  • Modelo / Serial
    List Number: 09P68‐01 Multiple serial numbers of the affected device are provided in the attached FSN.
  • Descripción del producto
    Analyzers, Laboratory, Clinical Chemistry/Immunoassay
  • Manufacturer
  • Modelo / Serial
  • Descripción del producto
    In-vitro diagnostics - haematological, histological and cytological products
  • Manufacturer
6 más