Events

Alerte De Sécurité sur Alere Triage Cardio 3

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong 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
    2014-02-20
  • Date de publication de l'événement
    2014-02-20
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140220a.html
  • 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: alere triage cardio 3 medical device manufacturer, alere, has issued a medical device safety alert concerning triage cardio 3 with catalogue number 97400 and lot number w53658b. according to the manufacturer, the affected product was investigated in response to date observed as part of the manufacturer’s routine product performance monitoring program. this lot shows lower than expected result for bnp, ckmb and troponin i which in turn could result in an increased rate of false negative results. testing of external controls would enable the lab to detect if this lot was giving lower than expected results at the time of testing. the manufacturer advises users of the followings: if users have questions about previously reported results, they should consult with resident clinical expert or physician in the setting where the test was performed. users should discontinue use of and discard the affected products. product replacement will be arranged by the manufacturer. according to the manufacturer, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 february 2014.

Device

Alere Triage Cardio 3
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Alere Triage Cardio 3
  • Manufacturer
    Alere

Manufacturer

Alere
  • 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
    DH