Alerte De Sécurité sur Monitoring systems Alere INRatio PT - INR

Selon National Authority of Drugs and Health Products (Infarmed, Portugal), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Portugal qui a été fabriqué par Alere.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2017-08-14
  • Pays de l'événement
  • Source de l'événement
    NADHPIP
  • URL de la source de l'événement
  • Notes / Alertes
    Portuguese data is current through October 2018. All of the data comes from the National Authority of Drugs and Health Products (Infarmed, Portugal), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Portugal.
  • Notes supplémentaires dans les données
  • Action
    Monitoring systems Alere INRatio PT - INR - Discontinuation of marketing

Device

Manufacturer

  • 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
    NADHPIP