Events

Rappel de Access Thyroglobulin Reagent Kit. An in vitro diagnostic medical device (IVD) For use with the Access Family of Immunoassay Systems including the Access 2, UniCel DxI 800 and UniCel DxI 600, UniCel DxC 600i, and the UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 660i systems.

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Beckman Coulter Australia 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-00724-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-08-07
  • 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-00724-1
  • 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 access thyroglobulin reagent pack lots may generate falsely elevated results at concentrations <10 ng/ml. the estimated maximum magnitude of the potential error in the affected range is a shift of up to 0.36 ng/ml high at concentrations <10 ng/ml. acceptable total imprecision was observed at values of 10 ng/ml and higher.
  • Action
    Beckman Coulter is requesting their customers to discard all Access Thyroglobulin reagent pack from the affected lots. Retesting should be carried out at the discretion of the laboratory director. This action has been closed-out on 26/08/2016.

Device

Access Thyroglobulin Reagent Kit. An in vitro diagnostic medical device (IVD) For use with the Ac...
  • Modèle / numéro de série
    Access Thyroglobulin Reagent Kit. An in vitro diagnostic medical device (IVD)For use with the Access Family of Immunoassay Systems including the Access 2, UniCel DxI 800 and UniCel DxI 600, UniCel DxC 600i, and the UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 660i systems.Product REF - 33860Lot Number:430969 431990 434727 522896 523251
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd