Events

Recall of FLUOROCELL PLT

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
    20245
  • Event Risk Class
    II
  • Event Initiated Date
    2017-09-15
  • 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
    There is a potential that fluorescent platelet (plt-f) and immature platelet fraction (ipf%) results performed using affected lots of fluorocell plt may exhibit lower than expected plt-f and ipf values on the xn-series analyzers. the issue may be recognized by a large discrepancy between the impedance platelet (plt-i) value and a false low plt-f value. in most cases the falsely decreased plt-f results displayed a "plt abn scattergram" message with asterisks beside the results indicating the data is unreliable. in rare instances platelet flags may be absent. the plt-i counts are unaffected. this instance is a recurrence of a previously reported issue under incident 132547 on july 2016.

Device

FLUOROCELL PLT
  • Model / Serial
    Model Catalog: CD-994-563 (Lot serial: >10 numbers contact mfg)
  • Product Description
    Fluorocell PLT
  • Manufacturer
    SYSMEX CANADA INC.

Manufacturer

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