Events

Rappel de ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - OXACILLIN

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
    73372
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-04-03
  • 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 qc failures (mic out of range high) for s.Aureus atcc 29213 strain on etest ox 256 (oxacillin) foam packaging (ref. 520518) reported from the field biomerieux initiated a complaint investigation to confirm product issue and determine root cause. the investigation confirmed a potential performance issue for s. aureus atcc 29213 qc strain and clinical staphylococcus strains on etest? ox 256 (oxacillin) foam packaging (ref. 520518) whatever the media used when compared to the agar dilution reference method that could lead to false resistant results. the investigation states that etest? ox 256 (oxacillin) spb configuration (ref.412432) performs within the expected specifications. as a result of the referenced issue there is a potential performance issue on strain categorization for staphylococcus strains that could lead to major errors when compared to the ad (agar dilution) reference method (resistant result instead of susceptible result) when using 2017 clsi or 2017 eucast standards.

Device

ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - OXACILLIN
  • Modèle / numéro de série
    Model Catalog: 520518 (Lot serial: 1004319590); Model Catalog: 520518 (Lot serial: 1004070580); Model Catalog: 520518 (Lot serial: 1004818850); Model Catalog: 520518 (Lot serial: 1003055340); Model Catalog: 520518 (Lot serial: 1003315740)
  • Description du dispositif
    ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - OXAC
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.