Events

Retiro De Equipo (Recall) de Radiometer immunoassay AQT90FLEX Analyser

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-2015-RN-00273-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-03-27
  • 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-2015-RN-00273-1
  • 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
    Radiometer has recently become aware of a potential significant clinical issue where a measured parameter with a positive result may be reported as being negative.The problem may occur in rare situations where the analyser uses an incorrect hct value equal to 0% possibly due to:· incorrect needle calibration in wash block after change of hct cell. · needle not sufficiently tightened after replacement. insufficient cleaning causing disrupted flow in the fluid path between wash block and needle. · air bubbles in the sample due to use of a different sample tube than recommended.
  • Acción
    A Radiometer Pacific representative will perform a test to determine if the analyser is affected and perform a correction to eliminate the risk. A software update is under development that will include an analysis process check to eliminate the possibility of this error. End users are requested to ensure that the mandatory ‘System Clean’ is performed regularly as instructed in the AQT90FLEX Instructions For Use. This action has been closed-out on 26/08/2016.

Device

Radiometer immunoassay AQT90FLEX Analyser
  • Modelo / Serial
    Radiometer immunoassay AQT90FLEX AnalyserARTG Number: 224867An in vitro diagnostic medical device (IVD).
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd