Home / Recalls / Sysmex America, Inc. / Z-0254-2013

Z-0254-2013 Class II Terminated

Recalled by Sysmex America, Inc. — Mundelein, IL

Recall Details

Product Type
Devices
Report Date
November 14, 2012
Initiation Date
June 1, 2012
Termination Date
August 22, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,099 units

Product Description

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.

Distribution Pattern

Nationwide distribution: USA including Puerto Rico.

Code Information

catalog #983-1341-1, all serial numbers

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