Events

Rappel de Radiometer ABL90 Series analysers with software version 3.2 or below. An in vitro diagnostic medical device (IVD)

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-2017-RN-00714-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-06-07
  • 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-2017-RN-00714-1
  • 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
    In august 2015 radiometer advised users about a potential issue (tga ref. rc-2015-rn-00805-1) where a battery module overheated caused by the continued charging of a failing battery cell. the temporary countermeasure recommended, after the battery modules below 910-311p0009nxxx had been replaced, was for the capacity of the battery module to be checked at least every 12 months following the instructions that were provided.The manufacturer has now released an upgrade of the abl90 series software to software version 3.3 or higher. this new version monitors the charge level for the battery. if one or more failing battery cells are detected, the analyser status turns yellow and message 1559 “battery error detected” appears. if message 1559 has been active for four weeks in a row, the analyser enters operator intervention required with message 1560 “battery error still detected” and the analyser is locked until the battery has either been removed or exchanged.
  • Action
    Radiometer will contact users to arrange for the installation of the software upgrade.

Device

Radiometer ABL90 Series analysers with software version 3.2 or below. An in vitro diagnostic medi...
  • Modèle / numéro de série
    Radiometer ABL90 Series analysers with software version 3.2 or below. An in vitro diagnostic medical device (IVD)All Serial NumbersARTG Number: 228382
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd