Events

Rappel de Radiometer ABL90 Flex analysers running V3.1MR1 or below

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-00124-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-02-17
  • 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-00124-1
  • 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 december 2014 radiometer pacific advised their customers of a potential significant clinical issue with patient results processed on the abl90flex analyser if the inlet is left open for more than 30 seconds after aspiration of the patient sample (rc-2014-rn-01365-1). although the analyser provides warning sounds and messages the problem can occur after the following sequence of actions:1. the operator aspirates patient sample a and forgets to close the inlet 2. the inlet is left open for more than 30 seconds before it is closed3. an operator aspirates patient sample bin this case the results for patient sample b are affected by this issue.Radiometer pacific advised a short term corrective action by providing a warning label for attachment to the analyser. this label provided instructions for action if the inlet has been left open.
  • Action
    A Radiometer Pacific representative will perform a software upgrade to version 3.1 MR3 on your ABL90Flex analyser to correct the issue and to remove the warning label issued as part of the original recall action. The recall for product correction letter will be provided to customers when the correction is carried out onsite. This action has been closed-out on 12/08/2016.

Device

Radiometer ABL90 Flex analysers running V3.1MR1 or below

Manufacturer

Radiometer Pacific Pty Ltd