Events

Rappel de Conveyor unit (CV-50) of Sysmex XN-9000 automated haematology analysers. 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-2018-RN-00501-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2018-05-24
  • 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-2018-RN-00501-1
  • 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 have been notified by the manufacturer, sysmex corporation, of a potential failure of power up due to a short circuit of the pcb of cv-50 power supply unit in the event a leakage occurs from the instrument or operator error. sysmex have identified that in rare cases, some fluid (approx 50ml) may leak from the xn-10 / xn-20 automated haematology analysers into the conveyor unit itself, resulting in short circuit of the power supply and subsequent malfunction of the conveyor. if this issue occurs, the system will stop and patient samples will require processing by manual measurement.Sysmex has received one complaint worldwide for this issue; none from australian customers to date.
  • Action
    Roche is advising they will be in contact with customers to arrange for a technician to ensure the gaps on the outer covers of the CV-50 will be sealed with waterproof materials. This will prevent fluid from entering the power supply board.

Device

Conveyor unit (CV-50) of Sysmex XN-9000 automated haematology analysers. An in vitro diagnostic m...
  • Modèle / numéro de série
    Conveyor unit (CV-50) of Sysmex XN-9000 automated haematology analysers. An in vitro diagnostic medical device (IVD)Material Number: 06510027001ARTG Number: 173886
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited