Events

Recall of RANGE CHECK X II

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
    87321
  • Event Risk Class
    III
  • Event Initiated Date
    2015-02-12
  • 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. received complaints from sysmex installation specialists and customers that level 2 of the five levels of white blood cell (wbc) linearity of range check xii (rcxll) was recovering above the expected range on the poch-1 ooi xp-300 and kx-21 n and kx-21 analyzers (three-part differential analyzers). level 2 wbc recovery is expected to be approximately 0.5 +/- 0.5 x103/ul and recovery was above 1.0 x103/ul in some instances. when the recovery is above 1.0 the plotted line is not straight suggesting the analyzer is not linear through the entire wbc reportable range of 1.0 to 99.9 x103/ul for the three part differential analyzers. exclusion of the level 2 produces a linear graph.

Device

RANGE CHECK X II
  • Model / Serial
    Model Catalog: 130-4003-0 (Lot serial: 5006 5076); Model Catalog: 130-4003-0 (Lot serial: 4091 4161 4231 4301)
  • Product Description
    Range Check X II
  • Manufacturer
    SYSMEX CANADA INC.

Manufacturer

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