Events

Recall of Coulter LH and HmX Analysers. 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-2017-RN-00820-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-06-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00820-1
  • 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 rare situations, the lh 750, lh 780, lh 500 and hmx analysers may not flag or detect blasts in some blood samples. this is due to limitations in the available technology as well as the properties of blasts in certain samples. if these limitations are not clearly understood or are misinterpreted, in rare situations there could be a delay in the recognition, diagnosis and treatment of conditions associated with blasts in the peripheral blood.
  • Action
    Users are asked to refer to the modified information for both the Suspect messages and Limitations sections for the Differential as contained in the Customer Letter.

Device

Coulter LH and HmX Analysers. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Coulter LH and HmX Analysers. An in vitro diagnostic medical device (IVD)Coulter LH 750 AnalyserReference Numbers: 6605632, A85570, A68807 Coulter LH 780 AnalyserReference No: 723585, A90728, A68808 Coulter LH 500 AnalyserReference No: 178832, 178833, 178834, A91062, A90994 Coulter HmX CP AnalysersReference No: 6605522, 6605523, 6605524 Coulter HmX AL AnalysersReference No: 6605525, 6605526, 6605527, A85566, A85564 All software versionsARTG Number: 177999
  • Product Classification
    Hematology and Pathology Devices
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd