Events

Rappel de Sysmex XN and XN-L Series - All Sysmex XN analysers versions 16 to 19

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-2015-RN-01165-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2015-12-09
  • 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-2015-RN-01165-1
  • 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 has been informed by sysmex that incorrect data transfer to the host computer may sporadically occur, when using the sysmex xn analysers, versions 16 to 19. this may lead to delays in reporting results and false negative results. under certain situations data may not be sent to the host computer, or incorrect data may be transferred. an example of incorrect data transfer may be if data is transferred as wbc, rbc, aso%, neut# and if this occurs at the transfer of baso% data, then all of the subsequent item’s data will be overwritten as baso% data. it has not yet been established which item overwrites the subsequent item’s data. if multiple samples were selected, and those selected samples were sent to the host computer as batch data, then this issue may be observed on multiple samples.
  • Action
    Roche Diagnostics will perform a software update on the affected devices. Roche is advising the users to investigate result transmission for data integrity if the error messages “TCP/IP send error occurred at host computer” or “Unable to establish TCP/IP connection with host computer” have been noticed prior to the software patch being installed. This action has been closed-out on 05/09/2016.

Device

Sysmex XN and XN-L Series - All Sysmex XN analysers versions 16 to 19
  • Modèle / numéro de série
    Sysmex XN and XN-L Series - All Sysmex XN analysers versions 16 to 19ARTG Number: 173886An in vitro diagnostic device
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited