Events

Avis De Sécurité sur Alere Triage BNP Test for Beckman Coulter Access Family Immunoassay Systems

Selon Swedish Medical Products Agency, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Sweden qui a été fabriqué par Alere San Diego, Inc. .

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici

Device

Alere Triage BNP Test for Beckman Coulter Access Family Immunoassay Systems
  • Modèle / numéro de série
  • Description du dispositif
    In-vitro diagnostic products
  • Manufacturer
    Alere San Diego, Inc.

Manufacturer

Alere San Diego, Inc.
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • 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
    SMPA