Events

Rappel de BK Virus R-gene

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 Biomerieux SA.

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
    20574
  • Date de mise en oeuvre de l'événement
    2016-08-29
  • 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: Medi'Ray New Zealand Ltd, 53-55 Paul Matthews Road, Albany, Auckland 0632
  • Cause
    Following a customer compaint about difficulties to interpret low viral load in whole blood samples, an investigation showed that the sensitivity of the bk virus r-gene® claimed in the ifu for whole blood was not confirmed., the issue is only impacting whole blood samples with a low viral load, where amplification leads to creeping/flat curves difficult to interpret., this issue has no impact on negative results or on high positive samples, as the amplification curves are well identified.
  • Action
    Manufacturer to issue advice regarding use

Device

BK Virus R-gene
  • Modèle / numéro de série
    Model: 69-013B, Affected: Lot numbers: 1003909940 1004754140 and 1004764070
  • Manufacturer
    Biomerieux SA

Manufacturer

Biomerieux SA