Events

Retiro De Equipo (Recall) de Abbot Architect 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 manufacturer #1479.

¿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
    19983
  • Fecha de inicio del evento
    2016-04-08
  • 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: Abbott Laboratories (NZ) Ltd, Ground Floor, Building D, 4 Pacific Rise, Mt Wellington, Auckland
  • Causa
    It has been confirmed that the drug fulvestrant (faslodex®) may interfere with the architect estradiol assay (ln 7k72) leading to falsely elevated estradiol results.The potential risk to health applies only to patients being treated with the drug fulvestrant which may lead to increased estradiol results.
  • Acción
    Product to be destroyed

Device

Abbot Architect Estradiol

Manufacturer

manufacturer #1479