Z-0254-2013Class II

Sysmex XE-2100 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe...

Name: Z-0254-2013 Sysmex XE-2100 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe...
Creator: Sysmex America, Inc.
Published: 2012-06-01
License: https://open.fda.gov/license/

Sysmex America, Inc. / initiated 2012-06-01 / Terminated / root cause: design

FDA source

Sysmex America, Inc. began a recall of Sysmex XE-2100 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White... on 2012-06-01. FDA classified it as Class II and gives the reason 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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0254-2013
Classification: Class II
Status: Terminated
Initiated: 2012-06-01
Posted: 2012-11-06
Terminated: 2016-08-22
Recalling firm: Sysmex America, Inc.
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.
Product code: GKZ Counter, Differential Cell
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.
Root cause tag: design
FDA root cause: Device Design
Action: Sysmex America, Inc. sent a "PRODUCT NOTIFICATION" letter dated May 2012 to all affected customers on June 1, 2012. The letter identifies the product, problem, and actions to be taken. The letter instructs customers to review patient results to determine if their Reference Intervals need adjustment, and to review QC results via Insight and document any change that may be linked to the date of calibration if appropriate. Any questions concerning the information contained in the notification were directed to the Sysmex Technical Assistance Center at 1-888-879-7639.
Quantity in commerce: 1,099 units
Distribution: Nationwide distribution: USA including Puerto Rico.
Product codes and lots: catalog #983-1341-1, all serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0254-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0254-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0255-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0256-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06

Product code GKZ

K992875Class IISysmex Xe-2100, Automatated Hematology AnalyzerSysmex Corp. / cleared 1999-11-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)