Events

Rappel de cobas 8000 core unit with software versions 5.01 and later. 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-2017-RN-01115-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-08-28
  • 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-2017-RN-01115-1
  • 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
    Due to a software limitation, in very rare cases, roche has identified that the system configuration of the control unit software may be reset to its default settings.For instruments which are connected to laboratory automation systems (clas) and/or are running in barcode mode, if the issue has occurred and at the start of the next operation:-barcodes are no longer read-rack loading from clas is no longer possible-additional settings may revert to default settings during operationroche has received 6 complaints globally to date; none from australian customers. there is a risk of incorrect results, especially when “alarm settings” and “analyzer settings” unknowingly revert to “default” settings.
  • Action
    1. If the software issue is detected, stop the instrument using the “Stop” button and contact the Roche Diagnostics Australia call centre on 1800 645 619, quoting the Roche reference number "CPS-2017-017". 2. After the system settings have been restored by Roche Diagnostics Australia personnel re-run any samples which were measured in the period between the issue occurring and the instrument being stopped. 3. Retain this letter until the software upgrade has been installed. 4. Acknowledge receipt of this communication via the link/email address in the supplied customer letter, even if no system which is subject to this recall is on-site, as this information is required to reconcile this process.

Device

cobas 8000 core unit with software versions 5.01 and later. An in vitro diagnostic medical device...
  • Modèle / numéro de série
    cobas 8000 core unit with software versions 5.01 and later. An in vitro diagnostic medical device (IVD)Material Number: 05641446001ARTG Number: 173887
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited