Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Sysmex XE-2100C Automated Hematology System Recalled by Sysmex America, Inc. Due to There is a variation of reticulocyte counts between...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Sysmex America, Inc. directly.
Affected Products
Sysmex XE-2100C Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #053-2311-4 The Sysmex XE-2100C is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.
Quantity: 69 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sysmex America, Inc.
Sysmex America, Inc. has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report