Events

Recall of XN-L series analyser

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
    21663
  • Event Initiated Date
    2017-07-05
  • 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
    It has been reported that the wbc could become falsely low when the following steps are performed:, manual mode is selected, whole blood mode (wb), predilute mode (pd) or body fluid mode (bf) is changed to low wbc mode (lw)., the measurement information is input in the manual order dialogue and the menu is closed by selecting 'ok'., no measurement is performed in lw mode, and the mode is then changed to use another measurement mode (ie either wb, pd, bf)., with the next measurement, the wbc result becomes diluted and gives a result half of the correct wbc value.
  • Action
    Software to be upgraded

Device

XN-L series analyser
  • Model / Serial
    Model: , Affected: XN-L series instruments: version 00-13 and above
  • Manufacturer
    Sysmex Corporation

Manufacturer

Sysmex Corporation