Retiro De Equipo (Recall) de AMH Gen II ELISA (clinical chemistry substrate, Anti-Mullerian Hormone assay). 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 Beckman Coulter 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-2012-RN-01227-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-12-05
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • 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
    Beckman coulter has confirmed through customer feedback and internal investigation that some samples diluted with the amh gen ii sample diluent prior to running the assay may generate results that are falsely elevated.
  • Acción
    Beckman Coulter is providing updated work around instructions to mitigate the issue and asking users to notify clinicians/research scientists regarding the potentially affected results at the discretion of the Laboratory Director.

Device

  • Modelo / Serial
    AMH Gen II ELISA (clinical chemistry substrate, Anti-Mullerian Hormone assay). An in vitro diagnostic medical device (IVD).Part number: A79765All lot numbers are affectedARTG number: 185654
  • Manufacturer

Manufacturer