Events

Rappel de PerkinEllmer LifeCycle for Prenatal Screening

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 PerkinElmer.

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
    12921
  • Date de mise en oeuvre de l'événement
    2012-12-03
  • 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: SciMed Ltd, Unit 2, 1 Tussock Lane, Ferrymead, Christchurch 8023
  • Cause
    Perkin elmer has become aware about lifecycle risk calculation problem that can potentially take place with assisted reproduction screening where an egg donor is involved. the change in calculated risk is dependent on the age difference between the mother and the egg donor. in the worst case, if the age of the mother is substantially higher than the egg donor's age. a true low risk value can be turned as high and thereby cause indirect harm because of possibility for an unnecessary medical intervention.
  • Action
    Software to be upgraded

Device

PerkinEllmer LifeCycle for Prenatal Screening
  • Modèle / numéro de série
    Model: 5002-0020, Affected: Software versions 3.0, 3.1, 3.2
  • Manufacturer
    PerkinElmer

Manufacturer

PerkinElmer