Events

Rappel de STA - Liatest vWF: Ag assay used with the STA-R/STA-R EVOLUTION analyser. An in vitro diagnostic medical device (IVD) for the measurement of von Willebrand factor.

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Diagnostica Stago Pty Ltd.

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-2013-RN-00042-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-01-17
  • 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-2013-RN-00042-1
  • 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
    Diagnostica stago has confirmed that the sta - liatest vwf: ag assay may produce falsely low results when testing some qc and patient samples.
  • Action
    Stago are advising users to confirm all results obtained in the abnormal range (under 50%) with a manual rerun or by the creation of a dependant test at a 1:2 dilution until a corrective action has been determined. If tests are already performed in duplicate, the requirement for follow up testing should be at the discretion of the laboratory manager.

Device

STA - Liatest vWF: Ag assay used with the STA-R/STA-R EVOLUTION analyser. An in vitro diagnostic ...
  • Modèle / numéro de série
    STA - Liatest vWF: Ag assay used with the STA-R/STA-R EVOLUTION analyser. An in vitro diagnostic medical device (IVD) for the measurement of von Willebrand factor.Ref: 00518ARTG: 185170
  • Manufacturer
    Diagnostica Stago Pty Ltd

Manufacturer

Diagnostica Stago Pty Ltd