Events

Recall of UniCel DxH 800 Coulter Cellular Analysis System and UniCel DxH 600 Coulter Cellular Analysis System

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-2017-RN-00556-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-05-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00556-1
  • 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
    There is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a system flag and/or message. the events associated with the unusual light scatter pattern may be incorrectly removed from analysis which can result in an erroneous differential result.In most cases, system flags and/or messages have accompanied the erroneous results, indicating the need to review the results. in rare instances, system flags and/or messages might be absent.
  • Action
    Users are requested to: 1. Use all available features to assess patient results, including reference ranges, action and critical limits, instrument system flags, codes, messages, delta checks, and decision rules; 2. Follow all Instructions for Use (IFU) pertaining to flow cell error and warning messages, and ensure daily Shutdown is performed; 3. Follow your laboratory’s standard operating procedure for confirming unexpected results; 4. Communicate to your Laboratory Medical Director the need to avoid patient treatment based solely on any single test result, and to interpret all results in the context of other clinical and laboratory features; and 5. Consult with your Medical Director to determine if a retrospective review of results is warranted. In the interim, Beckman Coulter is working on a permanent resolution to detect and flag these unexpected light scatter patterns.

Device

UniCel DxH 800 Coulter Cellular Analysis System and UniCel DxH 600 Coulter Cellular Analysis System

Manufacturer

Beckman Coulter Australia Pty Ltd