Events

Rappel de Radiometer ABL800 series blood gas analyser with FLEXQ module

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
    22096
  • Date de mise en oeuvre de l'événement
    2018-01-09
  • 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
    It has come to the manufacturers attention that in certain situations, the registration receipt received after placing a sampler in the flexq can be associated with a different sampler if the barcode quality on the receipt has been affected., update:, the manufacturer has now released the software upgrade version6.18 which is the corrective action for the issue reported., a checksum has been added to the barcode on the registration receipt to make the barcode more robust.
  • Action
    Software to be upgraded

Device

Radiometer ABL800 series blood gas analyser with FLEXQ module
  • Modèle / numéro de série
    Model: , Affected: Sampler Registration receipt data, All serial numbers
  • Manufacturer
    Radiometer Medical ApS

Manufacturer

Radiometer Medical ApS