Events

Recall of Conveyor unit (CV-50) of Sysmex XN-9000 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-2018-RN-00501-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2018-05-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00501-1
  • 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 have been notified by the manufacturer, sysmex corporation, of a potential failure of power up due to a short circuit of the pcb of cv-50 power supply unit in the event a leakage occurs from the instrument or operator error. sysmex have identified that in rare cases, some fluid (approx 50ml) may leak from the xn-10 / xn-20 automated haematology analysers into the conveyor unit itself, resulting in short circuit of the power supply and subsequent malfunction of the conveyor. if this issue occurs, the system will stop and patient samples will require processing by manual measurement.Sysmex has received one complaint worldwide for this issue; none from australian customers to date.
  • Action
    Roche is advising they will be in contact with customers to arrange for a technician to ensure the gaps on the outer covers of the CV-50 will be sealed with waterproof materials. This will prevent fluid from entering the power supply board.

Device

Conveyor unit (CV-50) of Sysmex XN-9000 automated haematology analysers. An in vitro diagnostic m...
  • Model / Serial
    Conveyor unit (CV-50) of Sysmex XN-9000 automated haematology analysers. An in vitro diagnostic medical device (IVD)Material Number: 06510027001ARTG Number: 173886
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited