Events

Recall of CYTOMICS FC 500 MPL (FLOW CYTOMETER) - MXP NEW USER SOFTWARE KIT V2.0

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
    65702
  • Event Risk Class
    II
  • Event Initiated Date
    2006-08-30
  • 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 generates incorrect statistics when a polygonal region with vertical re-entrant vertices is renamed or when a region is copied fron one plot to another and the new region is renamed.

Device

CYTOMICS FC 500 MPL (FLOW CYTOMETER) - MXP NEW USER SOFTWARE KIT V2.0
  • Model / Serial
    Model Catalog: (Lot serial: ALL)
  • Product Description
    Cytomics FC 500 with CXP & MXP Software
  • Manufacturer
    BECKMAN COULTER INC.

Manufacturer

BECKMAN COULTER INC.