Events

Recall of BODY FLUID CONTROL

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECKMAN COULTER CANADA L.P..

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
    107651
  • Event Risk Class
    III
  • Event Initiated Date
    2015-06-03
  • 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
    Beckman coulter has confirmed high and/or out-of-range values for total nucleated cells (tnc) on control level 1... when compared to the published table of expected results. the issue was initially reported in april 2015 by a united states customer. there has been no report of death or injury related to this issue.

Device

BODY FLUID CONTROL
  • Model / Serial
    Model Catalog: 628030 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    COULTER BODY FLUID CONTROL KIT LEVEL 1
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.