Events

Recall of BD FACSCANTO FLOW CYTOMETER - 7-COLOUR BEADS

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
    135963
  • Event Risk Class
    III
  • Event Initiated Date
    2012-07-11
  • 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
    The bd facs 7-color setup bead kit is shipped with a cd containing pass/fail values for the cytometer sensitivity test (part of cytometer qc). the incorrect version of the cd was included with bd facs 7-color setup beads (cat. no. 335775 lot no. 33412). the kit should have cd version 3.0 instead of 2.0. kit lot 33412 (part of "pl8" batches) was shipped with a cd containing pass/fail values for a different lot which was part of the "pl6" batches. the recall is specific only to the cd within the kit. the 7-color setup beads are not affected. bd is not requesting that the 7-color setup beads be destroyed.

Device

BD FACSCANTO FLOW CYTOMETER - 7-COLOUR BEADS
  • Model / Serial
    Model Catalog: 335775 (Lot serial: 33412)
  • Product Description
    BD FACS 7-Color Setup Beads
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.