Events

Rappel de AMH Gen II ELISA (clinical chemistry substrate, Anti-Mullerian Hormone 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 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-2012-RN-01227-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-12-05
  • 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-2012-RN-01227-1
  • 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
    Beckman coulter has confirmed through customer feedback and internal investigation that some samples diluted with the amh gen ii sample diluent prior to running the assay may generate results that are falsely elevated.
  • Action
    Beckman Coulter is providing updated work around instructions to mitigate the issue and asking users to notify clinicians/research scientists regarding the potentially affected results at the discretion of the Laboratory Director.

Device

AMH Gen II ELISA (clinical chemistry substrate, Anti-Mullerian Hormone assay). An in vitro diagno...
  • Modèle / numéro de série
    AMH Gen II ELISA (clinical chemistry substrate, Anti-Mullerian Hormone assay). An in vitro diagnostic medical device (IVD).Part number: A79765All lot numbers are affectedARTG number: 185654
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd