Events

Recall of UniCel DxH 600 & 800 Coulter Cellular Analysis Systems. 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-01651-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-12-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01651-1
  • 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 determined that additional clarification for the blast suspect messages is necessary. in certain situations, the unicel dxh 800 and dxh 600 coulter cellular analysis system may not flag or detect blasts in some blood samples. this is due to limitations in the available technology as well as sample limitations. in these situations there could be a delay in the diagnosis and treatment of conditions associated with blasts in the peripheral blood.
  • Action
    Beckman Coulter is providing users with information about limitations of the of the UniCel DxH 600 & 800 systems with respect to the flagging and detection of blasts in some blood samples. Detailed information will be provided in a customer letter and will also be temporarily available within the online ReadMefile, B44444AE, available on the Beckman Coulter website. Revised instructions that include this information will be available in March 2017. The information provided should be discussed with the Medical Director with respect to looking-back of previous patient results. In addition, the possibility of false negatives and the need for blood films should be considered.

Device

UniCel DxH 600 & 800 Coulter Cellular Analysis Systems. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    UniCel DxH 600 & 800 Coulter Cellular Analysis Systems. An in vitro diagnostic medical device (IVD).UniCel DxH 800 Reference Number: 629029, B24465, B24802, B68304UniCel DxH 600 Reference Number: B23858All software versionsARTG Number: 177999
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd