Events

Rappel de Sysmex XN-Series 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-00368-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-03-28
  • 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-00368-1
  • 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
    Reports have been received that the sysmex haematology analyser xn-series may generate an intermittent inaccurate low eosinophil count. patient samples analysed by the xn-series analyser reported 0% eosinophils count, but on subsequent manual review, up to 11% eosinophils were observed. this issue may lead to misdiagnosis or delay in treatment for conditions such as allergies or parasitic infections.
  • Action
    In order to detect the phenomenon, Roche is recommending users set up an Action comment or a Block Validate rule in the Rerun/Reflex/Comment Rule in the IPU settings when certain conditions are met. Users are advised that this action is currently undergoing validation and upon finalisation, a followup notification will be communicated to them. Users are also requested to discuss this matter with their Medical Director.

Device

Sysmex XN-Series Automated Haematology Analysers. An in vitro diagnostic medical device (IVD).
  • Modèle / numéro de série
    Sysmex XN-Series 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