Events

Rappel de Radiometer ABL90Flex analyser

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
    17922
  • Date de mise en oeuvre de l'événement
    2014-12-24
  • 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
    Manufacturer has become aware of a potential significant clinical issue with patient results if the inlet is left open after aspiration of the patient sample for more than 30 seconds., note that if the inlet is accidentally left open after processing a patient sample the abl90 analyser sounds a warning bell, places a warning message on the screen and also initiates a voice message continuously repeating "please close the inlet"., 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 closed, 3.An operator aspirates patient sample b, in this case the results for patient sample b are affected by this issue.
  • Action
    Instructions for use to be updated

Device

Radiometer ABL90Flex analyser

Manufacturer

Radiometer Medical ApS