Events

Rappel de ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - FOSFOMYCIN

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
    33638
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2016-12-28
  • 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
    As a part of an ongoing project regarding the analysis of stability data on etest range we have observed a decrease in the shelf life of the following etest products that requires your immediate attention to ensure improved use of the product within its revised shelf life of (24) months.

Device

ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - FOSFOMYCIN
  • Modèle / numéro de série
    Model Catalog: 529108 (Lot serial: More than 10 contact manuf.); Model Catalog: 513610 (Lot serial: More than 10 contact manuf.); Model Catalog: 512518 (Lot serial: More than 10 contact manuf.); Model Catalog: 512510 (Lot serial: More than 10 contact manuf.); Model Catalog: 506718 (Lot serial: More than 10 contact manuf.); Model Catalog: 535918 (Lot serial: More than 10 contact manuf.); Model Catalog: 529100 (Lot serial: More than 10 contact manuf.); Model Catalog: 513618 (Lot serial: More than 10 contact manuf.); Model Catalog: 525518 (Lot serial: More than 10 contact manuf.); Model Catalog: 525510 (Lot serial: More than 10 contact manuf.); Model Catalog: 522718 (Lot serial: More than 10 contact manuf.); Model Catalog: 502518 (Lot serial: More than 10 contact manuf.); Model Catalog: 508618 (Lot serial: More than 10 contact manuf.); Model Catalog: 508610 (Lot serial: More than 10 contact manuf.)
  • Description du dispositif
    ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - FOSFOMYCIN FM 1024 WW;ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - IMIPENEM IP 32 WW;ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - GENTAMICIN GM 256 WW;ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - CEFTAZIDIME TZ
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.