Events

Recall of Sysmex XN 10 and Xn 20

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Sysmex Corporation.

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
    21582
  • Event Initiated Date
    2017-06-23
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • Reason
    The manufacturer has informed that misalignment of the protective sheet on sysmex xn-10 and xn-20 analysers may lead to salt deposits, which could potentially build-up on the electronic components. in rare circumstances, this salt deposit build-up over time may become an internal combustion hazard.
  • Action
    Manufacturer to issue advice regarding use

Device

Sysmex XN 10 and Xn 20
  • Model / Serial
    Model: , Affected: XN-10: all instruments, XN-20: all instruments
  • Manufacturer
    Sysmex Corporation

Manufacturer

Sysmex Corporation