Events

Rappel de cobas 8100 BRF and URF with software versions 02-xx. 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-00373-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-03-22
  • 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-00373-1
  • 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
    An issue regarding the reformatter modules urf and brf of the cobas 8100 automated workflow series (when used with software version 02-xx) has been identified. this issue is caused by an incorrect mechanical control sequence based on a limitation in software versions 02-xx, resulting in the racks to be shaken and specimen spillage. sample spillage may cause cross contamination of samples and potentially expose operators to infectious material.
  • Action
    Until the installation of the software upgrade, Roche Diagnostics is advising users to ensure that the rack buffering function is disabled in the configuration of the Control Unit. In the event of a major spillage, users are advised to set the affected modules offline. These modules should be checked and cleaned by a Roche Service Representative before being returned to routine operation. This action has been closed-out on 15/03/2018.

Device

cobas 8100 BRF and URF with software versions 02-xx. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    cobas 8100 BRF and URF with software versions 02-xx. An in vitro diagnostic medical device (IVD)cobas 8100 automated workflow seriesBRF for cobas 8100Material Number: 07439954001URF for cobas 8100Material Number: 07441657001ARTG Number: 173887
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited