Events

Recall of FB REAGENT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BIOMERIEUX CANADA INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    27779
  • Event Risk Class
    II
  • Event Initiated Date
    2014-03-07
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    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
  • Product Description
    FB REAGENT
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.