Events

Rappel de Radiometer immunoassay AQT90FLEX Analyser

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Radiometer Pacific Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2015-RN-00273-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-03-27
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00273-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    Radiometer immunoassay AQT90FLEX AnalyserARTG Number: 224867An in vitro diagnostic medical device (IVD).
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd