Events

Rappel de Radiometer ABL800 series blood gas analysers

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Radiometer Medical ApS.

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
    21056
  • Date de mise en oeuvre de l'événement
    2017-04-06
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Radiometer Pacific, Unit 3, 33 Spartan Road, Takanini 2105
  • Cause
    On the abl800 series analyzers 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. an operator or clinician who is aware that the sample types that can be selected on abl800 series analyzer are cord blood arterial and cord blood venous may notice that a less specific sample type cord blood appears in the his/lis or middleware system., followup april 2017: the final solution to this issue is an upgrade of the abl800 software to software version 6.17 or higher. this new version ensures that cord blood arterial and cord blood venous are transmitted correctly to a his/lis or a middleware system.
  • Action
    Manufacturer to issue advice regarding use

Device

Radiometer ABL800 series blood gas analysers
  • Modèle / numéro de série
    Model: , Affected: All connected to HIS/LIS or middleware Data Management system
  • Manufacturer
    Radiometer Medical ApS

Manufacturer

Radiometer Medical ApS