Home / Recalls / Medical Devices
Sysmex America, Inc. recalls Sysmex XE-2100C Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; S
Recalled November 14, 2012 · FDA recall Z-0256-2013 · Sysmex America
Hazard
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 Class II
Units
69 units
Sold at
Nationwide distribution: USA including Puerto Rico.
Description
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.
Product
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.
Manufacturer(s)
Sysmex America, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →