Events

Rappel de Ki67-MM1 Bond Ready To Use, 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-00344-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-04-20
  • 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-00344-1
  • 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 some lot numbers do not consistently perform as expected and in some instances have exhibited weaker than expected staining. a false negative result could potentially result in the underestimation of the aggressiveness of a neoplasm, the mis-classification of a neoplasm, or failure to distinguish a benign process from a malignant one. any of these could result in the application of inappropriate treatment or delay in therapy. laboratories that follow procedures outlined in the products’ instructions for use (ifu) would identify the weak staining or negative staining in the tissue control.
  • Action
    Leica Biosystems is advising the users to return any unused product for a credit note. Leica Biosystems is advising users that clinical interpretation of staining or its absence should be evaluated within the context of the patient's clinical history and other diagnostic tests . A review of patient results may be warranted at the discretion of the pathologist. This action ha been closed-out on 31/08/2016.

Device

Ki67-MM1 Bond Ready To Use, An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Ki67-MM1 Bond Ready To Use, An in vitro diagnostic medical device (IVD)Product Code: PA0118Lot number: 28251Expiry Date: September 2017Lot number: 29784Expiry Date: January 2018Lot number: 29879Expiry Date: January 2018Lot number: 29880Expiry Date: January 2018Manufactured between September 2014 and January 2015.ARTG Number: 178442
  • Manufacturer
    Leica Microsystems Pty Ltd

Manufacturer

Leica Microsystems Pty Ltd