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U.S. Department of Health and Human Services

Class 2 Device Recall Sysmex XE5000 Automated Hematology System

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 Class 2 Recall
Sysmex XE5000 Automated Hematology System
see related information
Date Posted November 06, 2012
Recall Status1 Open
Recall Number Z-0255-2013
Recall Event ID 62580
Premarket Notification
510(K) Number
K071967 
Product Classification Counter, Differential Cell - Product Code GKZ
Product 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.
Code Information catalog #063-7591-7, all serial numbers
Recalling Firm/
Manufacturer
Sysmex America, Inc.
1 Nelson C White Pkwy
Mundelein, Illinois 60060-9528
Consumer Instructions Contact the recalling firm for information
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
DESIGN: 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 763 units
Distribution Nationwide distribution: USA including Puerto Rico.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GKZ and Original Applicant = SYSMEX AMERICA, INC.
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