Events

Retiro De Equipo (Recall) de LIAISON Estradiol II Gen Assay (used for the determination of estradiol in human serum). 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 DiaSorin Australia Pty Ltd.

¿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-00942-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-07-19
  • 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-00942-1
  • 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
    Diasorin is issuing a correction for the liaison estradiol ii gen assay. due to the risk of recently identified cross-reactivity, the liaison estradiol ii gen assay should not be used to test patients being treated with fulvestrant (faslodex). cross reactivity of the drug fulvestrant may lead to falsely elevated test results in estradiol assays. this is due to the fact that fulvestrant has a similar chemical structure to estradiol and may cross-react with antibodies used in immunoassays. fulvestrant is indicated for the treatment of post-menopausal women with estrogen receptor positive recurrent stage iv breast cancer.
  • Acción
    DiaSorin is advising users to use an alternative method if measuring estradiol levels in patients being treated with fulvestrant, and advise clinicians that Fulvestrant will increase the apparent concentration of estradiol in women being treated with this drug. It is recommended laboratories consider the need to carry out a review of previously generated results. DiaSorin will be updating the Instructions for Use (IFU) to contain additional warnings. This action has been closed-out on 22/02/2017.

Device

LIAISON Estradiol II Gen Assay (used for the determination of estradiol in human serum). An in vi...
  • Modelo / Serial
    LIAISON Estradiol II Gen Assay (used for the determination of estradiol in human serum). An in vitro diagnostic medical device (IVD)Part Number: 310680All Lots affectedARTG Number: 201366
  • Manufacturer
    DiaSorin Australia Pty Ltd

Manufacturer

DiaSorin Australia Pty Ltd