AxSYM Rubella IgG Reagent Pack

  • Modèle / numéro de série
    list 03B23; lot 49146M100
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    Worldwide, including USA, Puerto Rico, Argentina, Australia, Brazil, Canada, Cayman Islands, Chile, Colombia, Ecuador, Germany, Hong Kong, Mexico, New Zealand, Singapore, South Korea, Taiwan, Thailand and Venezuela.
  • Description du dispositif
    AxSYM Rubella IgG Reagent Pack; list 03B23; 100 test pack; an in vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064
  • Manufacturer
  • 1 Event


  • Adresse du fabricant
    Abbott Laboratories, 100 Abbott Park Rd, Abbott Park IL 60064-3502
  • 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

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  • Description du dispositif
  • Manufacturer