Sysmex XE-2100 Automated Hematology System — Class II medical device recall Z-0254-2013

Terminated recall by Sysmex America, Inc., reported 2012-11-14, distributed nationwide. There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (XT-2000i, XT-4

Recall number	`Z-0254-2013`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Sysmex America, Inc., Mundelein, IL, United States
Recall initiated	2012-06-01
Classified	2012-11-06
Reported by FDA	2012-11-14
Terminated	2016-08-22
Distributed	Nationwide (US)
Quantity	1,099 units
Model numbers	`983-1341-1`

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.

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0254-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.