Events

Rappel de Polymer Refine Red Detection (used for testing and identification of neoplasm). 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-2015-RN-01206-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-12-08
  • 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-01206-1
  • 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 detection kits may have been subject to a manufacturing error where some containers were under-filled and topped up with the incorrect reagent, leading to inadequate staining. if the product is used according to the instructions for use with the adequate controls, the end user would be able to identify the test has not stained correctly.
  • Action
    Leica Biosystems is advising users to discontinue use of the affected lot numbers and destroy any remaining stock. Leica Biosystems is recommending consulting with the Laboratory Director and Physician to determine if a review of past results is warranted. This action has been closed-out on 29/08/2016.

Device

Polymer Refine Red Detection (used for testing and identification of neoplasm). An in vitro diagn...
  • Modèle / numéro de série
    Polymer Refine Red Detection (used for testing and identification of neoplasm). An in vitro diagnostic medical device (IVD)Product Code: DS9390Lot Number: 41872 Expiry date: November 2016ARTG Number: 211376
  • Manufacturer
    Leica Biosystems Melbourne Pty Ltd

Manufacturer

Leica Biosystems Melbourne Pty Ltd