Events

Rappel de ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - TEICOPLANIN

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
    35426
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-12-14
  • 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
    Following an assessment of etest teicoplanin with staphylococcus spp. it has been observed that even though the mic essential agreement at +/- 1 dilution is les than 95% between etest tp256 and the reference method agar dilution (ad) for staphylococcus spp. an underestimation of mic values by at least 1 dilution has been observed for coagulase negative staphylococci (cons). this underestimation leads to a risk of false susceptible results linked in particular to the lack of an intermediate category interpretation if eucast breakpoints are applied for this antibiotic. during the study the false susceptible rate observed was 37.5% for cons where strains with an mic at 8 mg/ml by the reference method (resistant) can be found susceptible by etest teicoplanin.

Device

ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - TEICOPLANIN
  • Modèle / numéro de série
    Model Catalog: 522018 (Lot serial: More than 10 lots-contact man.); Model Catalog: 412461 (Lot serial: More than 10 lots-contact man.)
  • Description du dispositif
    ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - TEIC
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.