Events

Rappel de Sysmex XN-10 and XN-20 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-2017-RN-00585-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-05-18
  • 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-00585-1
  • 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 diagnostics australia has been informed by sysmex asia pacific that misalignment of the protective sheet on sysmex xn-10 and xn-20 analysers may allow potential leakage from fluidic parts to reach the electronic components. this leakage has the potential to result in the build-up of salt deposits on the electronic components which over time may present an internal combustion hazard.There has been one complaint worldwide relating to this issue. to date, no complaints have been received in australia.
  • Action
    Roche Diagnostics is advising customers that during the next immediate future service visit the technician will check the positioning of the protective sheet and verify that there is no leakage from the fluidic parts. If necessary, re-routing of the wiring bundle will be performed to eliminate interference and affected components replaced. In the interim, customers are requested not to attempt to inspect their instruments themselves as this area of the instrument is inaccessible to them.

Device

Sysmex XN-10 and XN-20 Automated Haematology Analysers. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Sysmex XN-10 and XN-20 Automated Haematology Analysers. An in vitro diagnostic medical device (IVD)ARTG Number: 173886
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited