Events

Recall of XN-L SERIES

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SYSMEX CANADA INC..

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
    25075
  • Event Risk Class
    III
  • Event Initiated Date
    2017-08-11
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    This correction alerts the customers to a software problem that causes possible false low wbc counts when using the low wbc mode. three other software anomalies related to abnormal sample flagging were also identified in this software version.

Device

XN-L SERIES
  • Model / Serial
    Model Catalog: XN-550 (Lot serial: >10 lot numbers contact mfg); Model Catalog: XN-450 (Lot serial: >10 lot numbers contact mfg)
  • Product Description
    XN-L SERIES
  • Manufacturer
    SYSMEX CANADA INC.

Manufacturer

SYSMEX CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Sysmex Corp.
  • Source
    HC