Events

Recall of Coulter S-CAL Calibrator Kits used on the Unicel DxH 800, DxH 600, LH 750 and LH 780 Systems.

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-01259-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-12-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01259-1
  • 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 received an increased number of customer complaints observed after s-cal calibration on the unicel dxh 800 and dxh 600 coulter cellular analysis systems, and the coulter lh 750 and lh 780 hematology systems. customers have reported a variety of issues during calibration including:- an increase in h&h; check messages- low mch recovery in xb- low mchc recovery in xbthese issues are not observed with all analysers and there is no impact to patient results.
  • Action
    Beckman Coulter is advising users to monitor other quality control performance and adhere to the established maintenance schedule. Beckman Coulter is adjusting the SCAL values for lots starting 4782 and 113160400. This action has been closed-out on 16/05/2017.

Device

Coulter S-CAL Calibrator Kits used on the Unicel DxH 800, DxH 600, LH 750 and LH 780 Systems.
  • Model / Serial
    Coulter S-CAL Calibrator Kits used on the Unicel DxH 800, DxH 600, LH 750 and LH 780 Systems. Catalogue Numbers: 624519, 179310 and 628026Multiple Kits and Vial Lot Numbers affectedAn in vitro diagnostic device (IVD)ARTG Number: 223050
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd