Alerte De Sécurité sur ARCHITECT Estradiol Reagent

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Abbott Laboratories Ltd.

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
    2016-04-06
  • Date de publication de l'événement
    2016-04-06
  • Pays de l'événement
  • Source de l'événement
    DH
  • URL de la source de l'événement
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: abbott architect estradiol reagent medical device manufacturer, abbott laboratories ltd, has issued a medical device safety alert concerning its architect estradiol reagent. [list number: 7k72; lot numbers: all]. the manufacturer has confirmed that the drug fulvestrant (faslodex) may interfere with the architect estradiol assay (ln 7k72) leading to falsely elevated estradiol results. the potential risk to health applies only to patients being treated with the drug fulvestrant which may lead to increased estradiol results. in worst case scenarios, falsely elevated estradiol results may lead to incorrect menopausal state assessment and inappropriate therapy. the manufacturer advises users that patients undergoing fulvestrant therapy should not be tested with the architect estradiol assay. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 6 april 2016.

Device

  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Abbott ARCHITECT Estradiol Reagent
  • Manufacturer

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
    DH
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