Recall Z-0254-2013— Sysmex America, Inc.

Name: FDA recall Z-0254-2013
Creator: U.S. Food and Drug Administration
Published: 2012-06-01

Class II · Terminated

Class II FDA medical device recall by Sysmex America, Inc., initiated 2012-06-01, terminated 2016-08-22. It names one FDA 510(k) clearance: K992875. 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: 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..

Recalling firm: Sysmex America, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-06-01
Terminated: 2016-08-22
Firm location: Mundelein, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K992875 — SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZERSysmex Corp.·cleared 1999-11-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.