Events

Recall of Sysmex XN and XN-L Series - All Sysmex XN analysers versions 16 to 19

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-2015-RN-01165-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-12-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01165-1
  • 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 has been informed by sysmex that incorrect data transfer to the host computer may sporadically occur, when using the sysmex xn analysers, versions 16 to 19. this may lead to delays in reporting results and false negative results. under certain situations data may not be sent to the host computer, or incorrect data may be transferred. an example of incorrect data transfer may be if data is transferred as wbc, rbc, aso%, neut# and if this occurs at the transfer of baso% data, then all of the subsequent item’s data will be overwritten as baso% data. it has not yet been established which item overwrites the subsequent item’s data. if multiple samples were selected, and those selected samples were sent to the host computer as batch data, then this issue may be observed on multiple samples.
  • Action
    Roche Diagnostics will perform a software update on the affected devices. Roche is advising the users to investigate result transmission for data integrity if the error messages “TCP/IP send error occurred at host computer” or “Unable to establish TCP/IP connection with host computer” have been noticed prior to the software patch being installed. This action has been closed-out on 05/09/2016.

Device

Sysmex XN and XN-L Series - All Sysmex XN analysers versions 16 to 19

Manufacturer

Roche Diagnostics Australia Pty Limited