CELL-DYN SAPPHIRE - ANALYZER

  • Modèle / numéro de série
    Model Catalog: 8H00-01 (Lot serial: REAGENT SYRINGES); Model Catalog: 8H00-01 (Lot serial: (08H49-02) LABELLED WITH); Model Catalog: 8H00-01 (Lot serial: PACKAGED DATES OF 16 SEPT 2008); Model Catalog: 8H00-01 (Lot serial: CELL-DYN SAPPHIRE HEMOGLOBIN)
  • Description du dispositif
    CELL-DYN SAPPHIRE ANALYZER
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    MISSISSAUGA
  • 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
    HC

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