Events

Recall of 8CHECK 3WP X-TRA CONTROL

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
    24300
  • Event Risk Class
    III
  • Event Initiated Date
    2013-12-04
  • 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
    Control product eightcheck 3wp xtra lot 3120 had an error on the pochi-100i assay barcode sheet for mean platelet volume (mpv) level 3 (l3). the barcode sheet had an incorrect mpv target value of 14.2 (correct value: 10.6). however the table of values on the assay sheet was correct with a value of 10.6 for mpv l3. all other assay values for lot 3120 were correct. the barcode discrepancy was reported to the technical assistance center which led to discovery of incorrrect bar code value for mpv l3 assay target. customer was preparing the poch-100i to use the new eightcheck 3wp xtra lot 3120 and noticed the discrepancy. the sai assay confimed the discrepancy and initiate orrective action.

Device

8CHECK 3WP X-TRA CONTROL
  • Model / Serial
    Model Catalog: 14030040 (Lot serial: 3120)
  • Product Description
    8CHECK 3WP X-TRA CONTROL
  • Manufacturer
    SYSMEX CANADA INC.

Manufacturer

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