Events

Recall of BD VACUTAINER CPT MONONUCLEAR CELL PREPARATION TUBE

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
    141195
  • Event Risk Class
    III
  • Event Initiated Date
    2014-06-30
  • 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
    Failure to conform to claim: clinical performance does not meet the supporting clinical study data for % recovery poor separation resulting in a reduced number of recovered mononuclear cells. having an insufficient number of isolated mononuclear cells may lead to possible specimen recollection potential delay of treatment and in remote cases it could lead to erroneous results. no adverse events have been reported for this issue.

Device

BD VACUTAINER CPT MONONUCLEAR CELL PREPARATION TUBE
  • Model / Serial
    Model Catalog: 362753 (Lot serial: 4063409); Model Catalog: 362761 (Lot serial: 4063409); Model Catalog: 362753 (Lot serial: 4090230); Model Catalog: 362761 (Lot serial: 4090230); Model Catalog: 362753 (Lot serial: 4090237); Model Catalog: 362761 (Lot serial: 4090237)
  • Product Description
    BD VACUTAINER CPT MONONUCLEAR CELL PREPARATION TUBE
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.