Food, drugs, devices › Sysmex America, Inc.

Device recall: Sysmex XE-2100 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sys

FDA enforcement event 62580 · Class II · initiated 1 Jun 2012 · status Terminated · terminated 22 Aug 2016

DeviceVoluntary: Firm initiated3 product recordsMundelein, IL

Sysmex America, Inc. (Mundelein, IL) initiated this device recall on 1 Jun 2012; FDA lists 3 product records under event 62580, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 823 device enforcement events initiated in 2012 carry the same class.

Status: Terminated, terminated 22 Aug 2016. Initiation: voluntary: firm initiated. Sysmex America, Inc. has 12 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Sysmex America, Inc., Mundelein, IL.

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

"Nationwide distribution: USA including Puerto Rico."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0254-2013	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…	1,099 units	Class II	Terminated	14 Nov 2012
Z-0255-2013	Sysmex XE-5000 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #063-7591-7 The Sysmex XE-5000 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations…	763 units	Class II	Terminated	14 Nov 2012
Z-0256-2013	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…	69 units	Class II	Terminated	14 Nov 2012

Context

88%of 2012 device events are Class II823 events that year

3product records in this eventfirm median: 1

12events on this register for the firm

Other enforcement events for Sysmex America, Inc.

Initiated	Product (first record)	Type	Class	Records
15 Dec 2025	TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running s	Device	Class II	1
6 Jan 2025	Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product usage for au	Device	Class II	1
6 Jul 2020	Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usage: is a fully automated, user configurable,	Device	Class II	1
9 Mar 2020	The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained blood smears	Device	Class II	1
21 Jan 2020	Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers.	Device	Class II	1
27 Jul 2018	Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.A. by Sysmex America, Inc., Lincolnshire, IL.	Device	Class II	1
8 Sep 2017	Sysmex Fluorocell(R) PLT Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platele	Device	Class II	1
23 Mar 2017	Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073	Device	Class II	1
1 Jul 2016	Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain platelets in a diluted blood sample for the co	Device	Class II	1
15 May 2013	pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1 Wakinohama	Device	Class II	1

All 12 events for Sysmex America, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "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."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide distribution: USA including Puerto Rico."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 22 Aug 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.