Events

Recall of CYTOMICS FC 500 FLOW CYTOMETER

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
    133045
  • Event Risk Class
    III
  • Event Initiated Date
    2013-08-28
  • 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
    Beckman coulter has determined that when the maintenance log for december is printed or savedentries for the subsequent eleven (11) months are lost and cannot be retrieved unless the database was backed-up prior to performing the print or save actions. for example if december 2012 is printed or saved any maintenance log entries for january-november 2013 will be lost. this issue can result in potentially incomplete maintenance log entries. no other report generator functions or patient results are affected by this issue.

Device

CYTOMICS FC 500 FLOW CYTOMETER
  • Model / Serial
    Model Catalog: 626553 (Lot serial: ALL LOTS); Model Catalog: 6605628 (Lot serial: ALL LOTS)
  • Product Description
    CYTOMICS FC 500 FLOW CYTOMETER
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.