Events

Rappel de Asserachrom Von Willebrand Factor (VWF):Collagen (CB). 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 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-2017-RN-00588-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-05-10
  • 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-00588-1
  • 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
    Following a customer complaint, stago has investigated and confirmed that asserachrom vwf:cb lot 114710(re) gives higher results compared to the other asserachrom vwf:cb tested lots for samples with a vwf:cb level above 30%. this issue is more pronounced for samples with a vwf:cb level above 50%.Based on internal testing by stago, normal samples tested are overestimated by 26% on average (relative deviation). for example: a normal plasma at 134% could be reported at 167%.The pathology samples tested and in particular the type 1 plasmas are overestimated by 38% on average (relative deviation). for example: a type 1 plasma at 56% could be reported at 75%.The quality control (qc) included in the kit does not always detect the issue.
  • Action
    Diagnostica Stago is advising users to stop using and destroy the affected lot according to current local regulations. Replacement kits will be provided.

Device

Asserachrom Von Willebrand Factor (VWF):Collagen (CB). An in vitro diagnostic medical device (IVD).
  • Modèle / numéro de série
    Asserachrom Von Willebrand Factor (VWF):Collagen (CB). An in vitro diagnostic medical device (IVD). Reference Number: 00239Lot Number: 114710(RE)ARTG Number: 185170
  • Manufacturer
    Diagnostica Stago Pty Ltd

Manufacturer

Diagnostica Stago Pty Ltd