ARCHITECT Anti-HBc II Reagent Kit

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
    AEMPSVFOI

3 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    Model: List Numbers: 8L44-25, 8L44-30, 8L44-35, Affected: Lot Numbers: 42072LI00, 42072LI01, 42253LI00, 42253LI01, 42255LI00, 42255LI01, 42256LI00
  • Manufacturer
  • Modèle / numéro de série
    List Number : 8L44-25 Lot Number : 42072LI00 Expiration Date 28-May-2015 List Number : 8L44-25 Lot Number : 42072LI01 Expiration Date : 28-May-2015 List Number : 8L44-25 Lot Number : 42253LI00 Expiration Date : 30-Jun-2015 List Number : 8L44-25 Lot Number : 42253LI01 Expiration Date : 30-Jun-2015 List Number : 8L44-30 Lot Number : 42255LI00 Expiration Date : 30-Jun-2015 List Number : 8L44-30 Lot Number : 42255LI01 Expiration Date : 30-Jun-2015 List Number : 8L44-35 Lot Number : 42256LI00 Expiration Date : 30-Jun-2015
  • Description du dispositif
    IVD
  • Manufacturer
  • Modèle / numéro de série
    ARCHITECT Anti-HBc II Reagent Kit. An in vitro diagnostic medical device (IVD)List Number: 8L44-25Lot Numbers:42072LI00, 42072LI01 (Expiry Date:28-May-2015) & 42253LI00, 42253LI01 (Expiry Date:30-Jun-2015)List Number: 8L44-30 Lot Numbers:42255LI00, 42255LI01(Expiry Date:30-Jun-2015)List Number: 8L44-35Lot Numbers: 42256LI00 (Expiry Date:30-Jun-2015)ARTG Number: 200673
  • Manufacturer