Events

Rappel de ABC1 HLA Typing Tray included in ABC1 / ABC2 Kits. 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-2017-RN-00169-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-02-08
  • 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-00169-1
  • 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
    Abc1 hla typing trays included in a single lot of acb1/acb2 kits contain a manufacturing defect that can result in false positive or false negative results.
  • Action
    Diagnostic Solutions is advising customers to immediately discontinue use of and destroy ABC1 HLA Typing Trays from the affected lot. Replacement kits will be provided. It is recommended that previously reported results are reviewed at the discretion of the clinical or laboratory director. This action has been closed out on 16 June 2017.

Device

ABC1 HLA Typing Tray included in ABC1 / ABC2 Kits. An in vitro diagnostic medical device (IVD).
  • Modèle / numéro de série
    ABC1 HLA Typing Tray included in ABC1 / ABC2 Kits. An in vitro diagnostic medical device (IVD).Product Code: GT-ABC1/2AULot Number: 3004753Expiration Date: 15 Nov 2017ARTG Number: 236406
  • Manufacturer
    Diagnostic Solutions Pty Ltd

Manufacturer

Diagnostic Solutions Pty Ltd