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
    86576
  • Event Risk Class
    III
  • Event Initiated Date
    2014-09-03
  • 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
    When the au480 clinical chemistry analyzer operates using the real-time online function and the number of barcode digits in the sample id barcode label does not match the instrument configuration setting in the "requisition format" menu and in the lis system the au480 clinical chemistry analyzer generates alarm 6042 "online mismatch" and the sample is not processed. if the number of barcode digits configured in the lis middle wareand au480 settings match the customer will not experience the issue. the issue does not generate incorrect results but may cause a delay in processing the sample.

Device

BECKMAN COULTER AU IMMUNOCHEMISTRY SYSTEM- AU480 ANALYZER
  • Model / Serial
    Model Catalog: AU480 (Lot serial: 2013082468); Model Catalog: AU480 (Lot serial: 2013072465)
  • Product Description
    Bekman Coulter AU Immunochemistry System-AU480
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.