Events

Recall of BD BACTEC FX

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECTON DICKINSON 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
    20715
  • Event Risk Class
    III
  • Event Initiated Date
    2010-08-13
  • 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
    Patient sample database on the bactec fx are sometimes found to be unusable upon rebooting the instrument. the reboot proceeds normally until it tries to load the database file at which point the instrument reboots and then repeats this cycle indefinitely or customers see a message on the display that says "please insert a bootable device". the system will continue to agitate and incubate the samples.

Device

BD BACTEC FX
  • Model / Serial
    Model Catalog: 441385 (Lot serial: FT0922); Model Catalog: 441385 (Lot serial: FT001 TO FT0906)
  • Product Description
    bactec fx
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.