Events

Retiro De Equipo (Recall) de AQURE POC Management System, software versions 1.4.0 to 1.5.3 (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 Radiometer Pacific 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-00275-1
  • 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-00275-1
  • 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
    Patient results are displayed with the incorrect unit of measure in aqure when:a) aqure is changed from the default setting for any or all parameters of international system of units to use non-international system of units (si units); andb) the result is outside reference and critical ranges; andc) aqure is being used to view the results.Results on the analyser and reported to the his/lis remain correct.
  • Acción
    End users are advised to view patient results in their HIS/LIS system and not in AQURE POC management system. Radiometer will provide an update to software version1.5.4 to correct this issue.

Device

AQURE POC Management System, software versions 1.4.0 to 1.5.3 (An in vitro diagnostic medical dev...
  • Modelo / Serial
    AQURE POC Management System, software versions 1.4.0 to 1.5.3 (An in vitro diagnostic medical device (IVD))
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd