Events

Retiro De Equipo (Recall) de AU5800 Clinical Chemistry Analyser; all instrument serial numbers with software version 4.11 and prior (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-2013-RN-00277-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-03-28
  • 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-00277-1
  • 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
    A software error has been identified that has the potential to cause the reporting of erroneous patient results due to mis-identification by the au5800 system.This issue only occurs if all the following conditions apply:a) the system is in "measure 1" mode during analysis (sequential, barcode or rack number mode)b) a manual batch requisition is initiatedc) lis is running in real time for tri (test requesting information) received) when events b and c (above) occur simultaneously.
  • Acción
    End users are advised of work around procedures to ensure erroneous results are not reported. Beckman Coulter will be addressing this issue in a future software update.

Device

AU5800 Clinical Chemistry Analyser; all instrument serial numbers with software version 4.11 and ...
  • Modelo / Serial
    AU5800 Clinical Chemistry Analyser; all instrument serial numbers with software version 4.11 and prior (An in vitro diagnostic medical device (IVD))ARTG Number: 177999
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd