Events

Recall of BECKMAN COULTER AU IMMUNOCHEMISTRY SYSTEM- AU480 ANALYZER

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
    127713
  • Event Risk Class
    III
  • Event Initiated Date
    2015-07-30
  • 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
    In march 2011 the material and molding process of the coolant cup (c cups) was changed. since the change beckman coulter has received complaints regarding leaking and cracked c cups. when this occurs coolant can leak onto and damage one of the printed circuit boards (pcbs) in the analyzers.

Device

BECKMAN COULTER AU IMMUNOCHEMISTRY SYSTEM- AU480 ANALYZER
  • Model / Serial
    Model Catalog: AU480 (Lot serial: >10 numbers contact mfg.); Model Catalog: AU5810 (Lot serial: >10 numbers contact mfg.); Model Catalog: AU5820 (Lot serial: >10 numbers contact mfg.); Model Catalog: AU680 (Lot serial: >10 numbers contact mfg.)
  • Product Description
    BECKMAN COULTER AU IMMUNOCHEMISTRY SYSTEM - AU480 ANALYZER
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.