Events

Retiro De Equipo (Recall) de DxH 500 Open-Vial Haematology System, with software version 1.0.2 and 1.1. 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-2017-RN-01401-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-11-08
  • 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-2017-RN-01401-1
  • 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
    An internal investigation has identified that if the bleach cycle is interrupted or aborted, the dxh 500 does not provide any warning message to the operator and the system does not sufficiently flush out residual bleach prior to sample analysis. should a bleach cycle get interrupted, the subsequent software recovery to perform a diluter reset may not be sufficient to prevent the first immediate sample run from being affected. this may result in incorrect patient results.There have been no reports of injuries as a result of this issue.
  • Acción
    Beckman Coulter is advising users that if the bleach cycle is interrupted or aborted to ensure the daily shutdown and daily checks are performed prior to running any patient samples. Beckman Coulter will be performing a software update as a permanent correction. A review of previously generated results is at the discretion of the laboratory director.

Device

DxH 500 Open-Vial Haematology System, with software version 1.0.2 and 1.1. An in vitro diagnostic...
  • Modelo / Serial
    DxH 500 Open-Vial Haematology System, with software version 1.0.2 and 1.1. An in vitro diagnostic medical device (IVD)Reference Number: B40601ARTG Number 208574
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd