Events

Rappel de ABL90 FLEX Analyser. An in vitro diagnostic medical device (IVD) (blood gas 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-2013-RN-01128-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-11-06
  • 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-2013-RN-01128-1
  • 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 issue of negative bias on sodium results if the abl90 is not on a horizontal table. when tilted by 10 degrees or more and idle for 30 -45 minutes the magnitude of the effect on sodium results is as large as 10 mm (7%) in the worst case.
  • Action
    Radiometer is advising users to ensure that the ABL90 is placed on a horizontal platform/table. If the analyser is on a roll stand users must ensure that the support plate is aligned horizontally and locked in position. Radiometer will perform alignment of roll stands on request. A detection mechanism will be provided in an upgraded version of the analyser software to eliminate the possibility of error.

Device

ABL90 FLEX Analyser. An in vitro diagnostic medical device (IVD) (blood gas analyser)
  • Modèle / numéro de série
    ABL90 FLEX Analyser. An in vitro diagnostic medical device (IVD) (blood gas analyser)
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd