Events

Recall of Sysmex XN-10 and XN-20 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-00585-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-05-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00585-1
  • 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
    Roche diagnostics australia has been informed by sysmex asia pacific that misalignment of the protective sheet on sysmex xn-10 and xn-20 analysers may allow potential leakage from fluidic parts to reach the electronic components. this leakage has the potential to result in the build-up of salt deposits on the electronic components which over time may present an internal combustion hazard.There has been one complaint worldwide relating to this issue. to date, no complaints have been received in australia.
  • Action
    Roche Diagnostics is advising customers that during the next immediate future service visit the technician will check the positioning of the protective sheet and verify that there is no leakage from the fluidic parts. If necessary, re-routing of the wiring bundle will be performed to eliminate interference and affected components replaced. In the interim, customers are requested not to attempt to inspect their instruments themselves as this area of the instrument is inaccessible to them.

Device

Sysmex XN-10 and XN-20 Automated Haematology Analysers. An in vitro diagnostic medical device (IVD)

Manufacturer

Roche Diagnostics Australia Pty Limited