Events

Retiro De Equipo (Recall) de A52103 Navios 10 Colours/3 Lasers, A52102 Navios 8 Colours/2 Lasers, A52101 Navios 6 Colours/2 Lasers (Navios Flow Cytometers). In vitro diagnostic medical devices (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-2013-RN-00056-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-01-21
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00056-1
  • 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 identified an internal wiring problem in certain navios reagent carts that may result in a severe shock hazard and instrument failure or shut down. during manufacture the compressor cable assembly may have been installed in a configuration that would allow the wiring to come into contact with the compressor frame during operation. normal vibration of the compressor frame could wear through the wiring's shielding and insulation material and connect electrical current to the reagent cart housing, resulting in the potential exposure of a user or service engineer to a severe shock hazard.
  • Acción
    If the compressor fails or the system shuts down unexpectedly, unplug the laboratory power source and call Beckman Coulter Customer Service. A Beckman Coulter service engineer will be contacting the affected customers to arrange for an inspection of the device and make all necessary corrections if an issue exists with the wiring within the compressor module.

Device

A52103 Navios 10 Colours/3 Lasers, A52102 Navios 8 Colours/2 Lasers, A52101 Navios 6 Colours/2 La...
  • Modelo / Serial
    A52103 Navios 10 Colours/3 Lasers, A52102 Navios 8 Colours/2 Lasers, A52101 Navios 6 Colours/2 Lasers (Navios Flow Cytometers). In vitro diagnostic medical devices (IVD)Part number A52101 serial numbers earlier than AU50137 are affectedPart number A52102 serial numbers earlier than AU50014 are affectedPart number A52103 serial numbers earlier than AU45311 are affected
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd