Events

Recall of XT-2000I ANALYZER

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
    103178
  • Event Risk Class
    II
  • Event Initiated Date
    2010-08-27
  • 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
    A design error introduced in the field programmable gate array (fpga) was discovered. this fpga is a logic circuit on a chip embedded on the printed computer board (pcb) in the main unit of the xt-series analyzers. the error can present as an increase in the platelet (plt) count of up to double the correct count and/or the generation of excessive plt sampling errors. the increase in count and errors is caused by the circuit seeing a single platelet and creating two pulses that are included in the reported plt count.

Device

XT-2000I ANALYZER
  • Model / Serial
    Model Catalog: 013-2531-8 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 013-2553-0 (Lot serial: S/N: 11165); Model Catalog: 013-2553-0 (Lot serial: S/N: 11232); Model Catalog: 023-0531-6 (Lot serial: S/N: 16975)
  • Product Description
    XT-2000I ANALYZER - SYSMEX HEMATOLOGY ANALYZERS
  • Manufacturer
    SYSMEX CANADA INC.

Manufacturer

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