Events

Rappel de Cobas EGFR MutationTest Kit(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 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-00091-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-02-06
  • 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-00091-1
  • 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
    The cobas egfr mutationtest, lot t08661 is generating false positive results for exon 20 insertion mutations (i.E., false mutation detected results). this mutation is typically only observed in 1-4% of the population depending on the geographic region. the issue is currently under investigation by roche. no other lots or pack sizes of this product are affected by this recall.
  • Action
    Roche Diagnostics Australia is requesting the customers to review their stocks, discontinue use and discard all remaining units of the above lot number. Roche Diagnostics Australia is providing replacement kits to the customers. This action has been closed-out on 15/08/2016.

Device

Cobas EGFR MutationTest Kit(An in vitro diagnostic medical device (IVD))
  • Modèle / numéro de série
    Cobas EGFR MutationTest Kit(An in vitro diagnostic medical device (IVD))Catalogue Number: 06471463190Lot Number: T08661ARTG number: 194319
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited