Events

Rappel de ENA RELISA Single Well Screen (576 well) Kit. 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-2015-RN-01194-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-12-07
  • 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-2015-RN-01194-1
  • 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
    Diagnostic solutions has been informed by immuno concepts that incorrect calibrator has been included with affected lots of the ena relisa single well screen kits. this may result in over-sensitivity and false positive patient results.
  • Action
    Diagnostic Solutions is advising users to inspect stock and destroy any remaining kits of the affected lots. Diagnostic Solutions is recommending that a review of previously reported results is performed at the discretion of the Laboratory Director. This action has been closed-out on 25/08/2016.

Device

ENA RELISA Single Well Screen (576 well) Kit. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    ENA RELISA Single Well Screen (576 well) Kit. An in vitro diagnostic medical device (IVD) Product Code: IC7696-10Lot Numbers:1525909 and 1525812 ARTG Number: 197980
  • Manufacturer
    Diagnostic Solutions Pty Ltd

Manufacturer

Diagnostic Solutions Pty Ltd