Events

Recall of AU680 chemistry analysers with software version 4.05. 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-2016-RN-01426-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-11-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01426-1
  • 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
    Beckman coulter has identified two issues occurring on au680 analysers installed with software version 4.05 that may cause a delay in reporting test results.Issue 1: only occurs with non-beckman coulter reagents. the “(” flag, which indicates a shortage of cleaning solution for contamination parameters, is unintentionally attached to test results depending on specific programming in the contamination parameters screen. there is no impact to test results, however the unintentional “(” flag may cause confusion regarding the volume of cleaning solution and unnecessary concern regarding potential carry-over.Issue 2: sample blank tests (total bilirubin and direct bilirubin) included in a qc profile are not analysed when requisitioned from the stat status > qc screen and run on the stat table. no qc results are initially generated for sample blank tests (total bilirubin and direct bilirubin). however, re-running the tests individually will generate the appropriate test results.
  • Action
    Beckman Coulter is providing temporary workarounds in the customer letter, in the form of step-by-step instructions to prevent each software issue. Beckman Coulter will resolve these issues in the next release of the AU680 software.

Device

AU680 chemistry analysers with software version 4.05. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    AU680 chemistry analysers with software version 4.05. An in vitro diagnostic medical device (IVD).ARTG Number: 236636
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd