Events

Retiro De Equipo (Recall) de Siemens IMMULITE/ IMMULITE 1000 Estradiol

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Siemens Healthcare Diagnostics Inc.

¿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
    19675
  • Fecha de inicio del evento
    2016-01-19
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • Causa
    Manufacturer has confirmed the drug fulvestrant (faslodec) may cause elevated estradiol results in the assays listed. fulvestrant is used in post-menopausal women treated for oestrogen receptor positive recurent stage 1v breast cancer.If the listed estradiol assays are used to assess the menopausal status of such a patient population, falsely elevated estradiol levels could lead the clinician to misinterpret the patient as premenopausal possbly leading to altered or discontinued use of the potential beneficial drug fulvestrant.
  • Acción
    Manufacturer to issue advice regarding use

Device

Siemens IMMULITE/ IMMULITE 1000 Estradiol

Manufacturer

Siemens Healthcare Diagnostics Inc
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    NZMMDSA