Events

Rappel de FB REAGENT

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
    27779
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-03-07
  • 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
    During the stability study of a new batch of zym b reagent (70493) a visual defect has been observed. after three months of stability this batch presents an heterogeneous aspect of color from yellow to red (a color yellow to amber is considered as conform according to the package insert). this visual defect is due to a specific new batch of raw material (lot mkbp5202v of fast blue bb salt sigma) used for the manufacturing of several batches of fb reagent and zym b reagent. as the involved batches of zym b reagent are included inside of api nh (10400) and api listeria (10300) kits the both references are also impacted.

Device

FB REAGENT
  • Modèle / numéro de série
    Model Catalog: 70562 (Lot serial: 1002717180); Model Catalog: 10400 (Lot serial: 1002869721); Model Catalog: 10400 (Lot serial: 1002869720); Model Catalog: 10400 (Lot serial: 1002826750); Model Catalog: 10400 (Lot serial: 1002814891); Model Catalog: 10400 (Lot serial: 1002814890); Model Catalog: 10400 (Lot serial: 1002809140); Model Catalog: 10400 (Lot serial: 1002786740); Model Catalog: 10300 (Lot serial: 1002856800); Model Catalog: 10300 (Lot serial: 1002856790); Model Catalog: 10300 (Lot serial: 1002587190); Model Catalog: 10300 (Lot serial: 1002569041); Model Catalog: 10300 (Lot serial: 1002569040); Model Catalog: 70493 (Lot serial: 1002860530); Model Catalog: 70493 (Lot serial: 1002857840); Model Catalog: 70493 (Lot serial: 1002821420); Model Catalog: 70493 (Lot serial: 1002760700); Model Catalog: 70493 (Lot serial: 1002742610); Model Catalog: 70493 (Lot serial: 1002717860); Model Catalog: 70493 (Lot serial: 1002706740); Model Catalog: 70562 (Lot serial: 1002877370); Model Catalog: 70562 (Lot serial: 10
  • Description du dispositif
    FB REAGENT
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.