Events

Rappel de ETEST® XM256 (Cefuroxime)

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
    21145
  • Date de mise en oeuvre de l'événement
    2017-02-23
  • 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
    Investigation confirmed a potential performance issue on strain categorization for streptococcus pneumoniae and for enterobacteriaceae strains limited to oral cefuroxim breakpoints and based on 2016 clsi clinical standards only., for streptococcus pneumoniae on etest® xm256 (cefuroxime) foam and spb could lead to minor error on clinical strains:, o false susceptible result instead of intermediate results with bmd (broth micro dilution) reference method, o false intermediate result instead of resistant results with bmd reference method, for enterobacteriaceae on etest® xm256 (cefuroxime) foam and spb could lead to minor error on clinical strains:, o false susceptible result instead of intermediate results with ad (agar dilution) reference method, o false intermediate result instead of resistant results with ad reference method.
  • Action
    Manufacturer to issue advice regarding use

Device

ETEST® XM256 (Cefuroxime)
  • Modèle / numéro de série
    Model: , Affected: ETEST XM256 (Cefuroxime) WW SPB lot number1002884720, ETEST XM256 (Cefuroxime) WW SPB lot number 1003383650, ETEST XM256 (Cefuroxime) WW Foam lot number 1003075850, ETEST XM256 (Cefuroxime) WW Foam lot number 1003385930
  • Manufacturer
    Biomerieux SA

Manufacturer

Biomerieux SA