Events

Rappel de ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - ERTAPENEM

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
    87481
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-04-06
  • 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
    Based on the strain epidemiology evolution with the detection of some streptococcus resistant strains from clinical specimens (around 1 and 5% according to clsi breakpoints) that did not exist at the moment of the product registration and as a part of the etest etp32 change impact study biomerieux initiated an internal study. the investigation results confirmed a potential performance issue on strain categorization for s. viridans group and s. pneumoniae based on 2017 clsi and eucast breakpoints that could lead to false susceptible result instead of resistant results on etest? etp32 (ertapenem) blister packaging when comparing to the broth-micro dilution (bmd) reference method. this performance issue was not evaluated at the time of product registration because rare or no resistant strains were reported at this time.

Device

ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - ERTAPENEM
  • Modèle / numéro de série
    Model Catalog: 531600 (Lot serial: More than 10 contact manuf.)
  • Description du dispositif
    ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - ERTA
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.