Events

Recall of Sysmex XN-Series Automated Haematology 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 Roche Diagnostics Australia Pty Limited.

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-00368-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-03-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00368-1
  • 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
    Reports have been received that the sysmex haematology analyser xn-series may generate an intermittent inaccurate low eosinophil count. patient samples analysed by the xn-series analyser reported 0% eosinophils count, but on subsequent manual review, up to 11% eosinophils were observed. this issue may lead to misdiagnosis or delay in treatment for conditions such as allergies or parasitic infections.
  • Action
    In order to detect the phenomenon, Roche is recommending users set up an Action comment or a Block Validate rule in the Rerun/Reflex/Comment Rule in the IPU settings when certain conditions are met. Users are advised that this action is currently undergoing validation and upon finalisation, a followup notification will be communicated to them. Users are also requested to discuss this matter with their Medical Director.

Device

Sysmex XN-Series Automated Haematology Analysers. An in vitro diagnostic medical device (IVD).

Manufacturer

Roche Diagnostics Australia Pty Limited