Events

Recall of BECKMAN COULTER AU5800 CLINICAL CHEMISTRY 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
    72300
  • Event Risk Class
    II
  • Event Initiated Date
    2013-05-24
  • 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
    Software error that results in the failure of the concentrated wash solution pump to stop creating an overflow or leak on each analyzer unit. the leak would be visually apparent and an on-screen and audible alarm "3639 master detergent overflow [unit #]" is generated alerting the operator of an instrument problem.

Device

BECKMAN COULTER AU5800 CLINICAL CHEMISTRY ANALYZER
  • Model / Serial
    Model Catalog: AU5830 (Lot serial: ALL); Model Catalog: AU5810 (Lot serial: ALL); Model Catalog: AU5840 (Lot serial: ALL); Model Catalog: AU5820 (Lot serial: ALL)
  • Product Description
    AU5800 CLINICAL CHEMISTRY ANALYZER
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.