Events

Rappel de PF4 IgG assay (Thrombophilia and coagulation inhibitor assay). 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 Diagnostic Solutions 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-2014-RN-01342-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-12-19
  • 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-2014-RN-01342-1
  • 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
    The manufacturer has determined that the pf4 concentrated wash (10x) lots indicated in this letter were manufactured at a slightly more dilute concentration. this may result in slightly increased optical density (positive bias) values with results generated using these buffer lots.
  • Action
    Diagnostic Solutions is requesting their customers to discard the affected kits. Replacement reagents will be provided. This action has been closed-out on 14/07/2016.

Device

PF4 IgG assay (Thrombophilia and coagulation inhibitor assay). An in vitro Diagnostic Medical Dev...
  • Modèle / numéro de série
    PF4 IgG assay (Thrombophilia and coagulation inhibitor assay). An in vitro Diagnostic Medical Device (IVD).Lot Numbers: 3001992 & 3002227ARTG Number: 217308
  • Manufacturer
    Diagnostic Solutions Pty Ltd

Manufacturer

Diagnostic Solutions Pty Ltd