Events

Rappel de Bond Ready-To-Use Primary Antibody Thyroglobulin (1D4) (An in vitro Diagnostic Medical Device (IVD)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Leica Biosystems Melbourne 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-2014-RN-00476-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-04-24
  • 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-2014-RN-00476-1
  • 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
    Leica biosystems recently became aware that the affected product does not function as intended up to the expiry date on the product labelling. this was detected through stability monitoring carried out by leica biosystems. there is a link between the age of the product and staining intensity.
  • Action
    Leica is requesting their customers to destroy any unused reagent from lot 24963 and confirm that the affected product is no longer in use.

Device

Bond Ready-To-Use Primary Antibody Thyroglobulin (1D4) (An in vitro Diagnostic Medical Device (IVD)

Manufacturer

Leica Biosystems Melbourne Pty Ltd