Events

Rappel de Product-CD30 (Ber-H2) Incorrect Primary Antibody Expiration Dating

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Roche Diagnostics Australia Pty Limited.

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-00690-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2015-07-28
  • 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-00690-1
  • 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
    Ventana medical systems, inc. (ventana) would like to inform you that the expiration date of the ventana cd30 (ber-h2) mouse monoclonal primary antibody (part number 790-4858, roche material number 07007841001) was inadvertently labelled with a 24 month expiration date for the referenced lot numbers. based on extensive testing of the affected lots, ventana can only support an 18 month expiration date.
  • Action
    Roche is requesting their customers to stop use of the affected product. Roche is also recommending that any clinical cases tested after the actual expiration date be re-tested in accordance with your local laboratory practices and policies, especially if tissue and/or same-slide controls were not performed in association with the original case. This action has been closed-out on 05/09/2016.

Device

Product-CD30 (Ber-H2) Incorrect Primary Antibody Expiration Dating
  • Modèle / numéro de série
    Product-CD30 (Ber-H2) Incorrect Primary Antibody Expiration DatingAffected lot numbers: D04835Z, D09123, E00209, E03668, E04391, E05896ARTG Number: 175635
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited