Events

Recall of Sysmex XN-450, XN-550 & other XN-L 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-00828-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-06-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00828-1
  • 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 potentially inaccurate wbc results could occur on the xn-l series analysers.It was reported that the wbc results could be false low when the following steps are performed:- the manual mode is selected- whole blood mode (diluent or body fluid mode) is changed to low wbc mode- measurement information is set with manual dialog and then closed by ok- no measurement obtained with low wbc mode and then the mode is changed to another measurement mode- the next measurement wbc result becomes half of the correct wbc valuethis issue may lead to incorrect diagnosis or treatment but this risk is mitigated when the clinical decision is made by considering the previous results, patient conditions and other test results. one complaint worldwide has been received (from japan) relating to this issue. no such complaints to date have been received in australia.
  • Action
    Roche will be contacting users to arrange the installation of a software upgrade to version 00-16A as a permanent fix. For previously affected results, users should discuss with their Medical Director whether a look-back is required.

Device

Sysmex XN-450, XN-550 & other XN-L series Automated Haematology Analysers. An in vitro diagnostic...
  • Model / Serial
    Sysmex XN-450, XN-550 & other XN-L series Automated Haematology Analysers. An in vitro diagnostic medical device (IVD)Analysers with s/w version 00-13 and above that have product licence for Low WBC modeARTG Number: 173886
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited