Events

Recall of 5C CELL 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
    32631
  • Event Risk Class
    III
  • Event Initiated Date
    2010-08-09
  • 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
    Potential for falsely low mean platelet volume (mpv) by up to 2 fl as a result of incorrect s-cal assay value assignments on control products. the deviation is not clinically significant and will not impact patient management or treatment decisions. the issue is exclusive to the mpv parameter.

Device

5C CELL CONTROL
  • Model / Serial
    Model Catalog: (Lot serial: >100 numbers contact mfg); Model Catalog: (Lot serial: >10 numbers contact mfg); Model Catalog: (Lot serial: > 10 numbers contact mfg)
  • Product Description
    5C Cell Control
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.