Events

Recall of Sysmex XN-550 Automated Haematology Analyser. 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-00485-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-05-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00485-1
  • 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
    Sysmex have found that that potentially inaccurate results could occur from improper mixing of a sample on the sysmex xn-550 automated haematology analyser with the following conditions:- the sample tube setup is for rbt micro collection tube or sarstedt sample tube, and- the xn-550 analyser is connected to a host computer and a host communication error occurs during a sampler run.If there is a sample tube located in the sample tube holder at this time, it will not be processed until the operator accepts the error message. sedimentation of the blood sample could occur during this time between error display and acceptance of the error, leading to potentially inaccurate results because the sample is processed without additional mixing. sysmex has found this issue is due to a software bug.
  • Action
    Roche is advising users that this issue will be resolved in a software update that is expected to be released in May 2017 and will be installed by Roche personnel. Roche will contact users to arrange for the installation. In the interim, laboratories that use RBT micro collection tubes and/or Sarstedt sample tubes are advised to follow the directions provided in the customer letter when an error message related to a host communication and/or TCP/IP connection occurs.

Device

Sysmex XN-550 Automated Haematology Analyser. An in vitro diagnostic medical device (IVD)

Manufacturer

Roche Diagnostics Australia Pty Limited