Events

Recall of XE-5000 HEMATOLOGY 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
    133382
  • Event Risk Class
    III
  • Event Initiated Date
    2012-07-13
  • 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 has determined that standardization and harmonization in reticulocyte counting between all instrument platforms would be of value and provide an overall benefit for patient testing. it is therefore recalibrating all xe-series instruments.

Device

XE-5000 HEMATOLOGY ANALYZER
  • Model / Serial
    Model Catalog: 063-7591-7 (Lot serial: > 10 NUMBERS CONTACT MFR); Model Catalog: 983-1341-1 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 053-2311-4 (Lot serial: F1069); Model Catalog: 053-2311-4 (Lot serial: F1066); Model Catalog: 053-2311-4 (Lot serial: F1067); Model Catalog: 053-2311-4 (Lot serial: F1068)
  • Product Description
    XE-5000 HEMATOLOGY ANALYZER
  • Manufacturer
    SYSMEX CANADA INC.

Manufacturer

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