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 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
    137696
  • Event Risk Class
    II
  • Event Initiated Date
    2007-05-09
  • 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
    The software can create a protocol which will not display the correct data in some plots and will not update the sample id1 field in the external worklist file.

Device

CYTOMICS FC 500 FLOW CYTOMETER
  • Model / Serial
    Model Catalog: (Lot serial: CXP Version 2.1 & 2.2)
  • Product Description
    Cytomics FC 500 Flow Cytometer
  • Manufacturer
    BECKMAN COULTER INC.

Manufacturer

BECKMAN COULTER INC.