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U.S. Department of Health and Human Services

Class 2 Device Recall Sysmex XE2100 Automated Hematology System

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  Class 2 Device Recall Sysmex XE2100 Automated Hematology System see related information
Date Initiated by Firm June 01, 2012
Date Posted November 06, 2012
Recall Status1 Open3, Classified
Recall Number Z-0254-2013
Recall Event ID 62580
510(K)Number K992875  
Product Classification Counter, differential cell - Product Code GKZ
Product Sysmex XE-2100 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #983-1341-1

The Sysmex XE-2100 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XE-2100 performs hematology analyses according to the RF/DC detection method, HydroDynamic Focusing (DC Detection), flow cytometry method (using a semiconductor laser), and SLS-hemoglobin method.
Code Information catalog #983-1341-1, all serial numbers.
Recalling Firm/
Sysmex America, Inc.
1 Nelson C White Pkwy
Mundelein IL 60060-9528
For Additional Information Contact
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Device Design
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.
Quantity in Commerce 1,099 units
Distribution Nationwide distribution: USA including Puerto Rico.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GKZ and Original Applicant = SYSMEX CORP.