Events

Recall of Sysmex XN-9000 Automated Haematology System. 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-00089-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-01-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00089-1
  • 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
    A remote possibility exists of incorrect allocation of customer demographic information against a sample in a specific situation. in a situation where the patient demographic information for a sample is not entered at the host computer and if the sample position is manually changed after being read by the barcode terminal, the customer demographics may be incorrectly allocated to the wrong patient results. one complaint worldwide has been received for this issue and in this instance, the user was not following the instructions for use, which clearly indicate that tubes should neither be removed nor inserted from the tube rack after a sample processing run has started. however, a software issue has also been identified with this system.
  • Action
    Sysmex is preparing a software patch for mandatory upgrade, which Roche Diagnostics’ personnel will install on the affected systems (software expected by end January 2017). Roche Diagnostics Australia will contact customers to arrange the install. In the interim, users are to ensure that: - They do not remove a rack in transit, or insert a rack or sample in anything other than the feeder when analysis is in progress; - If a STAT sample needs to be processed, they perform a manual analysis or off-line analysis; - If any sample results are sent to “Pending”, they perform a delta check; - Patient information is entered at the host computer and use both sample and patient ID. This action has been closed-out on 01/03/2018.

Device

Sysmex XN-9000 Automated Haematology System. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    Sysmex XN-9000 Automated Haematology System. An in vitro diagnostic medical device (IVD).Product Name/Code: XN-9000 Supply Parts AE415692Roche Material Number: 06509908001All Serial NumbersARTG Number: 173886
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited