Events

Rappel de Sysmex XN-550 Automated Haematology Analyser. 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-00485-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-05-04
  • 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-00485-1
  • 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
    Sysmex have found that that potentially inaccurate results could occur from improper mixing of a sample on the sysmex xn-550 automated haematology analyser with the following conditions:- the sample tube setup is for rbt micro collection tube or sarstedt sample tube, and- the xn-550 analyser is connected to a host computer and a host communication error occurs during a sampler run.If there is a sample tube located in the sample tube holder at this time, it will not be processed until the operator accepts the error message. sedimentation of the blood sample could occur during this time between error display and acceptance of the error, leading to potentially inaccurate results because the sample is processed without additional mixing. sysmex has found this issue is due to a software bug.
  • Action
    Roche is advising users that this issue will be resolved in a software update that is expected to be released in May 2017 and will be installed by Roche personnel. Roche will contact users to arrange for the installation. In the interim, laboratories that use RBT micro collection tubes and/or Sarstedt sample tubes are advised to follow the directions provided in the customer letter when an error message related to a host communication and/or TCP/IP connection occurs.

Device

Sysmex XN-550 Automated Haematology Analyser. An in vitro diagnostic medical device (IVD)

Manufacturer

Roche Diagnostics Australia Pty Limited