Events

Rappel de Cobas 8000 Patient sample and control recovery on Cobas c 701/702 modules (clinical chemistry analyser). 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-2012-RN-01113-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-11-01
  • 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-2012-RN-01113-1
  • 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
    A software bug has been detected on the cobas 8000, cobas c 701/702 modules, which under certain conditions can lead to a mismatch between reagent probe positioning during pipetting and the aspirate sample volumes, leading to possible incorrect results. until the new software version is available, roche have updated the application e-barcodes for the affected assays, which reduce the number of available tests.
  • Action
    Roche will be providing work around instructions to mitigate the risk and will be providing a software update to permanently correct the issue.

Device

Cobas 8000 Patient sample and control recovery on Cobas c 701/702 modules (clinical chemistry ana...
  • Modèle / numéro de série
    Cobas 8000 Patient sample and control recovery on Cobas c 701/702 modules (clinical chemistry analyser). An in vitro diagnostic medical device (IVD)Multiple affected assays
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited