Events

Retiro De Equipo (Recall) de AU5800 diluted detergent tank used with AU5800 Clinical Chemistry Analyser. 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-01140-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-11-09
  • 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-2012-RN-01140-1
  • 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
    If the au5800 diluted detergent tank valve is not positioned to 'closed' during the instrument 'measure' mode, diluted detergent will not be dispensed and may adversely affect washing of cuvettes, probes and mixing-bars. inadequate washing of cuvettes, probes and mixing bars can cause falsely high or low results to be reported for a variety of tests.
  • Acción
    Beckman Coulter is providing work around instructions to mitigate the issue and is asking customers to add a label to the diluted detergent tank identifying the "Open" and "Closed" orientation of the valve.

Device

AU5800 diluted detergent tank used with AU5800 Clinical Chemistry Analyser. An in vitro diagnosti...
  • Modelo / Serial
    AU5800 diluted detergent tank used with AU5800 Clinical Chemistry Analyser. An in vitro diagnostic medical device (IVD)Multiple models and catalogue numbersAll serial numbers affected
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd