Events

Recall of XN CHECK

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
    135645
  • Event Risk Class
    III
  • Event Initiated Date
    2016-03-29
  • 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
    Sysmex america inc. has become aware that the ipf% level 2 expected range was incorrectly reported for xn check lot numbers 6067 and 6068. the ipf% level 2 mean values are correct. appilcable instruments are xn-series (xn-10 xn-20 xn-11 xn-21) analyzers. assay sheets have been amended with the correct ipf% level 2 expected ranges. all other parameter means and expected ranges are correct. use of the original assay sheet may falsely indicate that the control is recovering outside of the true expected range.

Device

XN CHECK
  • Model / Serial
    Model Catalog: 213499 (Lot serial: 6068); Model Catalog: 213499 (Lot serial: 6067)
  • Product Description
    XN CHECK
  • Manufacturer
    SYSMEX CANADA INC.

Manufacturer

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