Events

Rappel de Sysmex XN-450, XN-550 & other XN-L 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-00828-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-06-29
  • 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-00828-1
  • 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 potentially inaccurate wbc results could occur on the xn-l series analysers.It was reported that the wbc results could be false low when the following steps are performed:- the manual mode is selected- whole blood mode (diluent or body fluid mode) is changed to low wbc mode- measurement information is set with manual dialog and then closed by ok- no measurement obtained with low wbc mode and then the mode is changed to another measurement mode- the next measurement wbc result becomes half of the correct wbc valuethis issue may lead to incorrect diagnosis or treatment but this risk is mitigated when the clinical decision is made by considering the previous results, patient conditions and other test results. one complaint worldwide has been received (from japan) relating to this issue. no such complaints to date have been received in australia.
  • Action
    Roche will be contacting users to arrange the installation of a software upgrade to version 00-16A as a permanent fix. For previously affected results, users should discuss with their Medical Director whether a look-back is required.

Device

Sysmex XN-450, XN-550 & other XN-L series Automated Haematology Analysers. An in vitro diagnostic...
  • Modèle / numéro de série
    Sysmex XN-450, XN-550 & other XN-L series Automated Haematology Analysers. An in vitro diagnostic medical device (IVD)Analysers with s/w version 00-13 and above that have product licence for Low WBC modeARTG Number: 173886
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited