Events

Retiro De Equipo (Recall) de PerkinEllmer LifeCycle for Prenatal Screening

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 PerkinElmer.

¿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
    12921
  • Fecha de inicio del evento
    2012-12-03
  • 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: SciMed Ltd, Unit 2, 1 Tussock Lane, Ferrymead, Christchurch 8023
  • Causa
    Perkin elmer has become aware about lifecycle risk calculation problem that can potentially take place with assisted reproduction screening where an egg donor is involved. the change in calculated risk is dependent on the age difference between the mother and the egg donor. in the worst case, if the age of the mother is substantially higher than the egg donor's age. a true low risk value can be turned as high and thereby cause indirect harm because of possibility for an unnecessary medical intervention.
  • Acción
    Software to be upgraded

Device

PerkinEllmer LifeCycle for Prenatal Screening
  • Modelo / Serial
    Model: 5002-0020, Affected: Software versions 3.0, 3.1, 3.2
  • Manufacturer
    PerkinElmer

Manufacturer

PerkinElmer