Events

Rappel de cobas 4800 - z 480 (Real time PCR sample preparation, amplification and detection instrument). 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-2013-RN-00278-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-03-28
  • 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-2013-RN-00278-1
  • 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
    Roche has advised that in rare instanced channel shifted results have been generated with cobas 4800 assays run on v1.X software of the cobas 4800 system. raw data review indicates that in these cases, all signals are shifted by one channel:- channel 1 results report as channel 2- channel 2 results report as channel 3- channel 3 results report as channel 4- channel 4 results report as channel 1. in the reported cases the results of the runs were either invalid or the preponderance of individual patient specimen showed to be invalid.
  • Action
    Roche is providing end users with work around instructions to mitigate the issue. A software update to detect and mitigate the issue will be implemented in late 2013. This action has been closed-out on 28/01/2016

Device

cobas 4800 - z 480 (Real time PCR sample preparation, amplification and detection instrument). An...
  • Modèle / numéro de série
    cobas 4800 - z 480 (Real time PCR sample preparation, amplification and detection instrument). An in vitro diagnostic medical device (IVD).All serial numbers affected
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited