Events

Recall of BECKMAN COULTER AU5400 CLINICAL CHEMISTRY SYSTEM - INSTRUMENT 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
    76895
  • Event Risk Class
    III
  • Event Initiated Date
    2012-05-17
  • 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
    Although the device will indicate when the ion selective electorde (ise) sample probe is fully occluded or near fully occluded as a result of a clot it may not alarm when only partially occluded.

Device

BECKMAN COULTER AU5400 CLINICAL CHEMISTRY SYSTEM - INSTRUMENT CLASS 2
  • Model / Serial
    Model Catalog: AU5431 (Lot serial: ALL); Model Catalog: AU5421 (Lot serial: ALL); Model Catalog: AU5400 (Lot serial: ALL)
  • Product Description
    AU5400 CHEMISTRY ANALYZER
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.