Retiro De Equipo (Recall) de BD FACSCanto 10 colour configuration (Cytometer). 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 Becton Dickinson 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-2014-RN-00627-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2014-06-18
  • 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
    Bd has determined that there is a problem with the laser cooling fans and the fluidics cart internal fan impacting bd facscanto. the instrument laser cooling fans and the internal fan of the associated fluidics cart are non-operational potentially affecting the life os the laser of the instrument. both problems are caused by a reversed wiring configuration that occurred during manufacturing.
  • Acción
    A BD service representative will contact the customer to arrange for correction. This action has been closed-out on 18/02/2016.

Device

  • Modelo / Serial
    BD FACSCanto 10 colour configuration (Cytometer). An in vitro diagnostic medical device (IVD)Serial Number: V65733800038ARTG Number: 188752
  • Manufacturer

Manufacturer