Events

Rappel de Radiometer pCO2 membrane (D788) for ABL7/8xx analyzers

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
    15014
  • Date de mise en oeuvre de l'événement
    2016-11-29
  • 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
    Possible negative bias on pco2 result on both blood and qc after membrane replacement. this bias can be seen after the replacement of the membrane., update: the temporary countermeasures, regarding the additional requirement for manually narrowing the qc ranges for pco2 and also performing extra qc measurements as communicated in july 2013 are no longer required and may be revoked upon installation of the improved sealing ring on the ph electrodes in abl700 and abl800 series analyzers., 01-02-2017: this notification is to inform you that your radiometer representative has now installed the improved sealing ring for the ph electrode in your abl700 and/or abl800 series analysers.
  • Action
    Manufacturer to issue advice regarding use

Device

Radiometer pCO2 membrane (D788) for ABL7/8xx analyzers
  • Modèle / numéro de série
    Model: Catalogue: 942-063, Affected: all lots
  • Manufacturer
    Radiometer Medical ApS

Manufacturer

Radiometer Medical ApS