Recall of ACCESS SYSTEM - TOTAL T4 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
    41834
  • Event Risk Class
    II
  • Event Initiated Date
    2011-07-28
  • Event Country
  • 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 inc. identified access total t4 calibrator lot 021654 do not meet their 12 month expiration date claim. patient and quality control results may be falsely decreased by 2 standard deviations or more. this decrease may be seen as early as ten months prior to the labeled calibrator expiration date.

Device

  • Model / Serial
    Model Catalog: 33805 (Lot serial: Total T4 Calibrators 021654); Model Catalog: 33800 (Lot serial: Total T4 Calibrators 021654)
  • Product Description
    ACCESS IMMUNOASSAY SYSTEMS TOTAL T4 CALIBRATORS
  • Manufacturer

Manufacturer