Events

Recall of XN-11 MODULE

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
    154783
  • Event Risk Class
    III
  • Event Initiated Date
    2017-02-07
  • 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
    Customer complaints identified two software vulnerabilities when using xn-series software version 00-16 through version 00-19. one software issue impacts all xn-series analyzer configurations the other occurs only with the xn-9000 configuration that consists of multiple xn-series analyzers on an automation line. a device correction is required for the xn-series hematology analyzers. this correction provides countermeasures to prevent incorrect demographic information and incorrect data transmission to the laboratory information system (lis). the correction was initiated on monday february 7 2017 in canada.

Device

XN-11 MODULE
  • Model / Serial
    Model Catalog: XN-11 (Lot serial: Serial # Range A1006-A1060); Model Catalog: XN-10 (Lot serial: Serial # range 11205 - 28242)
  • Product Description
    XN-11 MODULE;XN-10 MODULE
  • Manufacturer
    SYSMEX CANADA INC.

Manufacturer

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