Events

Recall of IMMAGE 800 IMMUNOCHEMISTRY SYSTEM

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
    129272
  • Event Risk Class
    III
  • Event Initiated Date
    2017-02-24
  • 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 immage cuvette sectors (p/n 470706) may be missing one of two positioning pins. cuvette sectors missing a positioning pin can become misaligned. if a cuvette sector becomes misaligned under rare circumstances the instrument mixer paddle may rub against the inside wall of the cuvette and create a noise.

Device

IMMAGE 800 IMMUNOCHEMISTRY SYSTEM
  • Model / Serial
    Model Catalog: A15445 (Lot serial: ALL); Model Catalog: A36035 (Lot serial: ALL)
  • Product Description
    IMMAGE 800 IMMUNOCHEMISTRY SYSTEM;RECONDITIONED IMMAGE
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.