Rappel de Radiometer ABL90 Flex blood gas analyser. 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
  • ID de l'événement
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
  • Pays de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • 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 that the abl90 flex in a very rare specific situation can aspirate calcium solution instead of rinse solution.The specific situation can occur when the following takes place:1. the analyser is in ready mode;2. operator lifts the inlet and then closes it again, thereby initiating a rinse; and3. immediately after lifts the inlet and quickly closes it again.In this situation, it will lead to several parameters reported incorrectly. some of the parameters will not have an error message or question mark indicating a problem with the result.
  • Action
    Radiometer are advising customers: 1. Inform users of the ABL90 FLEX analyser that the inlet is not to be repeatedly lifted and closed. If this does happen, the easiest way to reset the analyser flow selector manually is to re-install the solution pack. Follow the procedure described in the IFU for installation of a solution pack. Users may re-use the same solution pack; 2. It is recommended that users review previous results, where cNa+ and cCl- results are off from the expected results with the values found in table 1 stated in the customer letter; Radiometer will release a software solution (SW V 3.4) which corrects this issue. An updated IFU will also be provided to users upon completion of the software upgrade.