Events

Recall of Unicel DxH 800, SMS and 600 systems, with software versions 3.0.2.0 and 1.1.1.0. 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-2015-RN-01204-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-12-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01204-1
  • 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
    During internal testing, it was determined that the software for various dxh systems allows for the creation of multiple orders with the same specimen identification (id), but a different patient identification when manually editing pending orders at the system manager.This issue does not occur for edits of released results or for test orders requested through host transmission.There is a possibility of sample misidentification and the release of erroneous results.
  • Action
    Beckman Coulter is advising users not to edit the Specimen ID for a pending test order at the System Manager's Worklist. A software upgrade will be available to correct the issue. This action has been closed out on 13 Jun 2017.

Device

Unicel DxH 800, SMS and 600 systems, with software versions 3.0.2.0 and 1.1.1.0. An in vitro diag...
  • Model / Serial
    Unicel DxH 800, SMS and 600 systems, with software versions 3.0.2.0 and 1.1.1.0. An in vitro diagnostic medical device (IVD)Unicel DxH 800 Coulter Cellular Analysis SystemReference Numbers: 629029, B24465 and B24802Software version: 3.0.2.0Unicel DxH SMS Coulter Cellular Analysis SystemReference Numbers: 775222Software version: 3.0.2.0Unicel DxH 600 Coulter Cellular Analysis SystemReference Numbers: B23858Software version: 1.1.1.0ARTG Number: 177999
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd