Events

Rappel de Rack Trays used with cobas, Modular Analytics and Urisys instruments/systems. 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-2016-RN-01279-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-10-05
  • 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-2016-RN-01279-1
  • 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 is updating the cleaning procedure for rack trays that are used with various cobas, modular analytics and urisys instruments as a result of reports of injury caused by sharp edges on the rack trays during cleaning. cuts may occur when fingers come in contact with rack tray edges, especially if a quick wiping movement is made along the edges of the rack tray. the updated cleaning procedure contains instructions for safe handling of the parts to avoid the risk of injury.
  • Action
    Roche is providing users with updated cleaning instructions for the rack trays. This information will be incorporated into future versions of the respective instrument Operator Manuals. This action has been closed-out on 17/05/2017.

Device

Rack Trays used with cobas, Modular Analytics and Urisys instruments/systems. An in vitro diagnos...
  • Modèle / numéro de série
    Rack Trays used with cobas, Modular Analytics and Urisys instruments/systems. An in vitro diagnostic medical device (IVD). Various Rack Trays and instruments affectedMultiple Material Numbers affectedARTG Numbers: 173887 & 212706
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited