Events

Recall of BACT/ALERT PF PLUS CULTURE BOTTLE

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
    33870
  • Event Risk Class
    III
  • Event Initiated Date
    2013-10-17
  • 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
    Bact/alert pf plus culture bottle lot 1033633 yielded reflectace results above the stability specification at the 11-month timeframe. bottles that have reflectance results near or greater than the initial value threshold specification when first loaded on the instrument could have an increased probability of false positive results.

Device

BACT/ALERT PF PLUS CULTURE BOTTLE
  • Model / Serial
    Model Catalog: 410853 (Lot serial: Lot #1033633)
  • Product Description
    BACT/ALERT PF PLUS CULTURE BOTTLE
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.