Events

Retiro De Equipo (Recall) de Elecsys Estradiol Assay with Fulvestrant. An in-vitro diagnostic medical device (IVD)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Roche Diagnostics Australia Pty Limited.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2016-RN-00482-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-04-21
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00482-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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