Events

Rappel de ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - CEFUROXIME

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par BIOMERIEUX CANADA INC..

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
    23127
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-01-25
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    An analysis was performed on the essential agreement rate reflecting the mic result obtained by the product for a significant strains kit including enterobacteriaceae haemophilus and s. pneumoniae. species. then an additional analysis was done on the clinical categorization of the strains based on clsi guidance. the following have been identified: the investigation confirmed a potential performance issue on strains 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 that could lead to minor error on clinical strains :false susceptible result instead of intermediate results with bmd (broth micro dilution) reference method. false intermediate result instead of resistant results with bmd reference method _ for enterobacteriaceae on etest? xm256 (cefuroxime) foam and spb that could lead to minor error on clinical strains: false susceptible result instead of intermediate results with ad (agar dilution) reference method. false intermediate result instead of resistant results with ad reference method products perform within the specification when using the 2016 eucast guidelines.

Device

ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - CEFUROXIME
  • Modèle / numéro de série
    Model Catalog: 412305 (Lot serial: More than 10 contact manuf.); Model Catalog: 506918 (Lot serial: More than 10 contact manuf.)
  • Description du dispositif
    ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - CEFU
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.