Events

Recall of Device Recall Sysmex XE5000 Automated Hematology System

According to U.S. Food and Drug Administration, this recall involved a device in United States 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
    62580
  • Event Risk Class
    Class 2
  • Event Number
    Z-0255-2013
  • Event Initiated Date
    2012-06-01
  • Event Date Posted
    2012-11-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113586
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Counter, differential cell - Product Code GKZ
  • Reason
    There is a variation of reticulocyte counts between xe series (xe-2100, xe-5000) and xt-series (xt-2000i, xt-4000i) hematology analyzers that may result in a retic counts that are an average of 21% lower on the xe-series because of a low bias.
  • Action
    Sysmex America, Inc. sent a "PRODUCT NOTIFICATION" letter dated May 2012 to all affected customers on June 1, 2012. The letter identifies the product, problem, and actions to be taken. The letter instructs customers to review patient results to determine if their Reference Intervals need adjustment, and to review QC results via Insight and document any change that may be linked to the date of calibration if appropriate. Any questions concerning the information contained in the notification were directed to the Sysmex Technical Assistance Center at 1-888-879-7639.

Device

Device Recall Sysmex XE5000 Automated Hematology System
  • Model / Serial
    catalog #063-7591-7, all serial numbers
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA including Puerto Rico.
  • Product Description
    Sysmex XE-5000 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #063-7591-7 || The Sysmex XE-5000 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XE-5000 performs analyses using the following methods: RF/DC Detection Method, Sheath Row DC Detection Method, and Flow Cytometry Methods using a Semiconductor Laser. Particle characterization and identification is based on detection of forward scatter, fluorescence and adaptive cluster analysis. Using the same reagents as the XE-2100, the XE-5000 automatically classifies cells from blood and body fluids and carries out all processes automatically from aspiration of the sample to outputting the results.
  • Manufacturer
    Sysmex America, Inc.

Manufacturer

Sysmex America, Inc.
  • Manufacturer Address
    Sysmex America, Inc., 1 Nelson C White Pkwy, Mundelein IL 60060-9528
  • Manufacturer Parent Company (2017)
    Sysmex Corp.
  • Source
    USFDA