Events

Rappel de Radiometer ABL800 Series Analysers (used with software version 3.1 MR5). 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-00137-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-01-25
  • 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-00137-1
  • 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
    On the abl800 series analysers, the sample type “cord blood” has been changed into the two sample types “cord blood arterial” and “cord blood venous". this change took place with software version 3.1 mr5. despite the selected sample type being correctly displayed on the abl800 series analyser itself, the analyser will transmit the less specific sample type "cord blood" to a his/lis or middleware system. the described error may in a worst-case scenario lead to minor foetal hypoxic stress not being immediately recognised if the clinician was to use data from the his/lis or middleware system to determine treatment. this may cause a minor delay of necessary treatment of the newborn infant.
  • Action
    Radiometer is advising operators and clinicians using the "cord blood" sample results from a HIS/LIS or a middleware system to determine treatment to be aware that "arterial" or “venous" is not transmitted from the Analysers. Users are further advised that they will be notified when the new software fix is available for installation.

Device

Radiometer ABL800 Series Analysers (used with software version 3.1 MR5). An in vitro diagnostic m...
  • Modèle / numéro de série
    Radiometer ABL800 Series Analysers (used with software version 3.1 MR5). An in vitro diagnostic medical device (IVD).All Serial Numbers connected to HIS/LIS or middleware Data Management systemARTG Number: 228382
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd