Events

Rappel de Lysercell WDF 2 x 4L used on 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-00159-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-02-01
  • 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-00159-1
  • 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 received several reports that lysercell wdf 2 x 4l lots a6028, a6029 and a6030 can lead to an increased occurrence (up to 3-fold) of the flag “blast/abn lympho?” . no other flags have been observed. this issue leads to an increase in the “blast/abn lympho?” flagging rate and unnecessary manual review. the risk of a misdiagnosis is mitigated by the fact that any flags observed from the affected instruments must be confirmed by a qualified morphologist using a manual blood film.
  • Action
    Roche is advising customers to immediately discontinue use of and quarantine affected lots. New replacement lots will be provided by Roche.

Device

Lysercell WDF 2 x 4L used on Sysmex XN-Series Automated Haematology Analysers. An in vitro diagno...
  • Modèle / numéro de série
    Lysercell WDF 2 x 4L used on Sysmex XN-Series Automated Haematology Analysers. An in vitro diagnostic medical device (IVD).Material Number: 06510221001Lot Numbers: A6028, A6029, A6030ARTG Number: 188498
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited