Events

Rappel de NCL-L-CD15. An in vitro diagnostic medical device (IVD).(NovocastraT Liquid Mouse Monoclonal Antibody)

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-01357-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-12-23
  • 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-01357-1
  • 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 product listed above does 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. no customer complaints relating to this issue have been received. there is the potential risk of a patient being diagnosed with incorrect tumor based on a false negative cd15 staining result. delay in diagnosis/ misdiagnosis of a patient with hodgkin’s disease. positive control tissue would show weaker than expected or negative staining. an unexpected result would be highlighted by the use of appropriate controls. additionally, if a pathologist did not follow standard medical practice there could be a possibility that an incorrect or delayed diagnosis could result and appropriate treatment for the patient could be delayed. this could possibly result in improper staging of the patient’s disease or resulting in the patient’s death.
  • Action
    End users are requested to discard any remaining product from the affected lot and contact their Leica representative immediately if a replacement is required.

Device

NCL-L-CD15. An in vitro diagnostic medical device (IVD).(NovocastraT Liquid Mouse Monoclonal Anti...

Manufacturer

Leica Biosystems Melbourne Pty Ltd