Events

Recall of BECKMAN COULTER AU IMMUNOCHEMISTRY SYSTEM - AU680 INSTRMENT - CLASS 2

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
    27050
  • Event Risk Class
    II
  • Event Initiated Date
    2013-08-22
  • 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 confirmed that some au clinical chemistry analyzer ise units can experience premature ise ref (reference) valve failure. premature valve failure can be detected by the presence of air bubbles in the ise ref solution tubing on the ise unit. if air bubbles are present accuracy of the ise test results may be affected.

Device

BECKMAN COULTER AU IMMUNOCHEMISTRY SYSTEM - AU680 INSTRMENT - CLASS 2
  • Model / Serial
    Model Catalog: AU680 (Lot serial: ALL); Model Catalog: AU480 (Lot serial: ALL); Model Catalog: AU640 (Lot serial: ALL); Model Catalog: AU5840 (Lot serial: ALL); Model Catalog: AU5810 (Lot serial: ALL); Model Catalog: AU5820 (Lot serial: ALL); Model Catalog: AU5830 (Lot serial: ALL); Model Catalog: AU5400 (Lot serial: ALL); Model Catalog: AU2700 (Lot serial: ALL); Model Catalog: AU400 (Lot serial: ALL)
  • Product Description
    BECKMAN COULTER AU680 CHEMISTRY ANALYZER
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.