Events

Rappel de QConnect HBVNAT Positive

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Thermo Fisher Scientific Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2015-RN-01050-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2015-11-05
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01050-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Certain lot numbers of the qconnect hbvnat positive control may give no results due to ic (internal control) failure when run on the abbott m2000.The affected lot numbers should not be run on the abbott m2000.To ensure all affected lots have been destroyed the respective product specialist for each area will visit each site to confirm there is no stock still in possession.
  • Action
    Users are asked to quarantine all affected units from use prior to destruction. To ensure all affected lots have been destroyed the respective Product Specialist for each area will visit each site to confirm there is no stock still in possession. This action has been closed-out on 22/08/2016.

Device

QConnect HBVNAT Positive

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd