Events

Recall of STEMONE SYSTEM FOR EPICS - STEM-TROL

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
    71320
  • Event Risk Class
    III
  • Event Initiated Date
    2011-02-28
  • 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
    Lots 24 and 25 state wrong expiration date of 2010 july 26 instead of 2010 june 26.

Device

STEMONE SYSTEM FOR EPICS - STEM-TROL
  • Model / Serial
    Model Catalog: (Lot serial: lot 25); Model Catalog: (Lot serial: lot 26); Model Catalog: (Lot serial: lot 24); Model Catalog: (Lot serial: lot 27)
  • Product Description
    Stem-Trol Control Cells
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.