Events

Rappel de Elecsys Estradiol Assay with Fulvestrant. 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 Roche Diagnostics Australia Pty Limited.

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-00482-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-04-21
  • 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-00482-1
  • 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
    Roche diagnostics has tested for fulvestrant interference / cross-reactivity with the elecsys estradiol assay; this investigation has shown that fulvestrant could potentially affect patient sample results. the reported issue may lead to falsely elevated results of estradiol. subsequently, misinterpretation of the hormone status could occur and the use of fulvestrant may be altered. in addition, the efficiency of anti-estrogen treatment might be underestimated.
  • Action
    Roche is advising customers that Fulvestrant will increase the apparent concentration of estradiol in women being treated with this drug. A review of estradiol assay results in patients taking fulvestrant is recommended. A disclaimer will be added to the “Interference – Limitations” section in the Method Sheet of the Elecsys Estradiol III assay: This action has been closed-out on 30/01/2017. “Due to the risk of cross reactivity, this assay should not be used when monitoring estradiol levels in patients being treated with Fulvestrant.”

Device

Elecsys Estradiol Assay with Fulvestrant. An in-vitro diagnostic medical device (IVD)

Manufacturer

Roche Diagnostics Australia Pty Limited