Events

Rappel de VITEK 2 COMPACT 30 SYSTEM - SUSCEPTIBILITY TEST CARDS

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
    34992
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2013-12-24
  • 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
    There have been recent complaints that the vitek 2 meropenem (mem mem02n) is overcalling resistance for isolates of aeromonas hydrophila. false resistance was confirmed when isolates from customer sites were tested internally by broth microdilution (bdm) the reference method used for development of mem02n.

Device

VITEK 2 COMPACT 30 SYSTEM - SUSCEPTIBILITY TEST CARDS
  • Modèle / numéro de série
    Model Catalog: 413085 (Lot serial: ALL LOT NUMBERS); Model Catalog: 413082 (Lot serial: ALL LOT NUMBERS); Model Catalog: 413066 (Lot serial: ALL LOT NUMBERS); Model Catalog: 413063 (Lot serial: ALL LOT NUMBERS); Model Catalog: 413062 (Lot serial: ALL LOT NUMBERS); Model Catalog: 411021 (Lot serial: ALL LOT NUMBERS); Model Catalog: 410102 (Lot serial: ALL LOT NUMBERS); Model Catalog: 416710 (Lot serial: ALL LOT NUMBERS); Model Catalog: 414125 (Lot serial: ALL LOT NUMBERS); Model Catalog: 410101 (Lot serial: ALL LOT NUMBERS); Model Catalog: 413710 (Lot serial: ALL LOT NUMBERS); Model Catalog: 413143 (Lot serial: ALL LOT NUMBERS); Model Catalog: 413083 (Lot serial: ALL LOT NUMBERS)
  • Description du dispositif
    VITEK 2 SYSTEM - SUSCEPTIBILITY TEST CARDS
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.