Events

Rappel de Novocastra Lyophilised Mouse Monoclonal Antibody CD10 Reagents. 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 Microsystems 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-00892-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-09-14
  • 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-00892-1
  • 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 novocastra lyophilised mouse monoclonal antibody cd10 reagent lots do not function as intended up to the expiry date on the product labelling. there is a link between the age of the product and staining intensity, which may result in inadequate staining and lead to weak or false negative pathology results. this could potentially result in misclassification of a neoplasm and inappropriate management.
  • Action
    Leica Biosystems is advising users to cease use and destroy any remaining stocks of affected product. A review of previously obtained results is recommended at the discretion of the laboratory director and physician. This action has been closed-out on 03/03/2017.

Device

Novocastra Lyophilised Mouse Monoclonal Antibody CD10 Reagents. An in vitro diagnostic medical de...
  • Modèle / numéro de série
    Novocastra Lyophilised Mouse Monoclonal Antibody CD10 Reagents. An in vitro diagnostic medical device (IVD).Product Code: CD10-270-CELot Number: 6032742ARTG Number: 178442
  • Classification du dispositif
    Hematology and Pathology Devices
  • Manufacturer
    Leica Microsystems Pty Ltd

Manufacturer

Leica Microsystems Pty Ltd