Events

Rappel de FIDS dsDNA Kit (used for the detection and monitoring of Systemic Lupus Erythematosis (SLE)). 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-2016-RN-01184-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-09-08
  • 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-2016-RN-01184-1
  • 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 the manufacturer that there is an issue with the stability of the calibrator in the kit. an increase of fluorescence was observed during the ageing of the calibrator and therefore a decrease in patient results.
  • Action
    Diagnostic Solutions to advising users to inspect stock and destroy any remaining kits of the affected lots. Affected stock will be replaced with unaffected product. It is recommended that previously reported results are reviewed at the discretion of the laboratory director. This action has been closed-out on 11/05/2017.

Device

FIDS dsDNA Kit (used for the detection and monitoring of Systemic Lupus Erythematosis (SLE)). An ...
  • Modèle / numéro de série
    FIDS dsDNA Kit (used for the detection and monitoring of Systemic Lupus Erythematosis (SLE)). An in vitro diagnostic medical device (IVD)Product Code: BM-MX005-sLot Number: LE124535Expiry: 31 Jan 2018ARTG Number: 198370
  • Manufacturer
    Diagnostic Solutions Pty Ltd

Manufacturer

Diagnostic Solutions Pty Ltd