Events

Recall of UniCel DxH 600 and DxH800 Coulter Cellular Analysis System. 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-01093-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-08-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01093-1
  • 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 the possibility of specimen mis-identification for the stand-alone dxh 800 and dxh 600 where the primary identifier is configured to tube position id. this issue does not occur if the primary identifier is configured as specimen id. results from a patient control sample could be misidentified by being associated with a pending test order for a patient sample already on the worklist when the following sequence of events occurs:- the primary identifier is tube position id.- a patient control file is setup for id xxxxx, and a pending test order for a patient sample id xxxxx is subsequently added to the worklist.- the patient control sample is analysed using cassette presentation, but that tube does not contain a barcode-labelled specimen id or the label cannot be read.Upon analysis, the results from the analysed patient control tube will be associated with the patient sample that was pending on the worklist and not the patient control file.
  • Action
    Beckman Coulter is advising users to ensure there are no pending or active test orders in the worklist before analysing a patient control with a Tube Position ID. Beckman Coulter is investigating the issue in order to determine a resolution.

Device

UniCel DxH 600 and DxH800 Coulter Cellular Analysis System. An in vitro diagnostic medical device...
  • Model / Serial
    UniCel DxH 600 and DxH800 Coulter Cellular Analysis System. An in vitro diagnostic medical device (IVD)UniCel DxH 600Reference Numbers: 629029, B24465, B24802, B68304 UniCel DxH 800Reference Number: B23858 All software versionsARTG Number: 177999
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd