Events

Recall of SYSMEX E-CHECK

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SYSMEX AMERICA 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
    31223
  • Event Risk Class
    III
  • Event Initiated Date
    2016-01-07
  • 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 basophil percent and absolute count (baso%/baso#) for e-check(xe) (part #201-6001-0) is occasionally not recovering within the assay range for level 1 of lot 5336 expiration date february 22 2016. level 2 and level 3 are not affected and are recovering within assay ranges.

Device

SYSMEX E-CHECK
  • Model / Serial
    Model Catalog: 201-6001-0 (Lot serial: 5336)
  • Product Description
    SYSMEX E-CHECK (XE) QUALITY CONTROL
  • Manufacturer
    SYSMEX AMERICA INC.

Manufacturer

SYSMEX AMERICA INC.
  • Manufacturer Address
    LINCOLNSHIRE
  • Manufacturer Parent Company (2017)
    Sysmex Corp.
  • Source
    HC