Events

Recall of AU5800 Clinical Chemistry Analyser; all instrument serial numbers with software version 4.11 and prior (An in vitro diagnostic medical device (IVD))

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Beckman Coulter Australia Pty Ltd.

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
    RC-2013-RN-00277-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-03-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00277-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    A software error has been identified that has the potential to cause the reporting of erroneous patient results due to mis-identification by the au5800 system.This issue only occurs if all the following conditions apply:a) the system is in "measure 1" mode during analysis (sequential, barcode or rack number mode)b) a manual batch requisition is initiatedc) lis is running in real time for tri (test requesting information) received) when events b and c (above) occur simultaneously.
  • Action
    End users are advised of work around procedures to ensure erroneous results are not reported. Beckman Coulter will be addressing this issue in a future software update.

Device

AU5800 Clinical Chemistry Analyser; all instrument serial numbers with software version 4.11 and ...
  • Model / Serial
    AU5800 Clinical Chemistry Analyser; all instrument serial numbers with software version 4.11 and prior (An in vitro diagnostic medical device (IVD))ARTG Number: 177999
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd