Home / Recalls / Sysmex America, Inc. / Z-0256-2013

Z-0256-2013 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
69 units

Product Description

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.

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 ##053-2311-4, all serial numbers

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