Events

Recall of ACCESS SYSTEM - CEA ASSAY

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
    132489
  • Event Risk Class
    II
  • Event Initiated Date
    2006-04-19
  • 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
    Access cea may generate erroneously low cea values after samples have been frozen. product insert directs customers to freeze samples if assay will not be completed within 48 hours or for shipment of samples.

Device

ACCESS SYSTEM - CEA ASSAY
  • Model / Serial
    Model Catalog: 33200 (Lot serial: All lots)
  • Product Description
    Access Immunoassay System CEA
  • Manufacturer
    BECKMAN COULTER INC.

Manufacturer

BECKMAN COULTER INC.