Events

Recall of ACCESS SYSTEM - FREE T3 ASSAY

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
    17638
  • Event Risk Class
    II
  • Event Initiated Date
    2015-08-31
  • 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 some access free t3 reagent packs (p/n a13422) of lot 431433 were filled incorrectly. these packs contained insufficient quantity of reagents in one or more of the pack wells. affected reagent packs have the potential to generate incorrect control and patient results dependant upon the instrument and software version installed at the time the reagent lot was in use.

Device

ACCESS SYSTEM - FREE T3 ASSAY
  • Model / Serial
    Model Catalog: A13422 (Lot serial: 431433)
  • Product Description
    ACCESS SYSTEM - FREE T3 ASSAY
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.