Events

Recall of UniCel DxH 600 & 800 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-2013-RN-01277-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-11-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01277-1
  • 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
    Update: beckman coulter's investigation has shown that the dxh cleaner were the main contributor to the optical degradation issue.Complaints related to optical degradation have increased on the dxh 800 and dxh 600 systems. customers have reported that they are experiencing an increase in one or more of the following:- flow cell clogs (::::)- ls offset errors during daily check or control analysis- high coefficients of variation (cv) for latron cp-x controls for low angle light scatter (lals) and/or axial light loss (all) parameters- system messages and r-flagged results for nrbc, diff and retic during control or patient analysis, such as partial clogs (low event rated with diff rs) or a voltage failure (system event: d with diff rs)the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells, white blood cell differential and/or reticulocytes.
  • Action
    Update: Beckman Coulter is requesting their customers to discard the affected lot of DxH Cleaner. Laboratories can discontinue the additional flush flow cell and cleaning actions. Beckman Coulter is recommending users perform a Flush Flow Cell, Extended Cleaning and perform a routine shutdown at least daily. A permanent fix will be implemented when available.

Device

UniCel DxH 600 & 800 Coulter Cellular Analysis System. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    UniCel DxH 600 & 800 Coulter Cellular Analysis System. An in vitro diagnostic medical device (IVD)UniCel DxH 600 Coulter Cellular Analysis SystemPart Number: B23858UniCel DxH 800 Coulter Cellular Analysis SystemPart Number: 6290029
  • Product Classification
    Hematology and Pathology Devices
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd