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Sysmex America, Inc.

Last updated September 17, 2026

Information

Country: US
Address: 577 Aptakisic Rd, Lincolnshire, IL, 60069
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EUDAMED SRN: —
FDA FEI Number: 3009711478
DUNS Number: —

Catalogue (34)

Device	Model / Reference	Registries	Class	Status
XR-Series (XR-10	K253212	FDA 510(k)	Class II	Active
Sysmex UF1000i, Automated Urine Particle Analyzer with Urinalysis WAM Software	UF-1000i with UF WAM	FDA UDI	Class II	Active
Caresphere Workflow Solution	1.X	FDA UDI	Class I	Active
WAM (Work Area Management)	5.X	FDA UDI	Class I	Active
Sysmex Xt-Series Ig Parameter, Sysmex Xt-Series Ret-He Parameter	K081890	FDA 510(k)	Class II	Active
Sysmex Poch-100i	K032677	FDA 510(k)	Class II	Active
Ipf (immature Platelet Fraction) Parameter On The Sysmex Model Xe-2100 Automated Hematology Analyzer	K051199	FDA 510(k)	Class II	Active
Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device	K182062	FDA 510(k)	Class II	Active
Sysmex Xe-5000	K071967	FDA 510(k)	Class II	Active
XW-100 Automated Hematology Analyzer for CLIA Waived Use	K172604	FDA 510(k)	Class II	Active
XW-100 Automated Hematology Analyzer, XW QC CHECK	K143577	FDA 510(k)	Class II	Active
Sysmex Model Xs-1000ic Automated Hematology Analyzer	K081610	FDA 510(k)	Class II	Active
Sysmex Xn-Series	K112605	FDA 510(k)	Class II	Active
Sysmex Model Xt-4000i	K091313	FDA 510(k)	Class II	Active
Sysmex UF-5000 Fully Automated Urine Particle Analyzer	K171883	FDA 510(k)	Class II	Active
Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer	K230887	FDA 510(k)	Class II	Active
Sysmex XW-100 Automated Hematology Analyzer	K210346	FDA 510(k)	Class II	Active
Sysmex Automated Hematology Analyzer Models Xs Series	K060656	FDA 510(k)	Class II	Active
Sysmex Xn Series	K141681	FDA 510(k)	Class II	Active
Automated Blood Coagulation Analyzer CN-Series (CN-6000)	K250965	FDA 510(k)	Class II	Active
Sysmex XN-L Automated Hematology Analyzer	K182389	FDA 510(k)	Class II	Active
Sysmex XN-L Automated Hematology Analyzer	K160538	FDA 510(k)	Class II	Active
Immature Granulocyte (ig) Parameter On The Sysmex Model Xe-2100 Automated Hematology Analyzer	K032039	FDA 510(k)	Class II	Active
Sysmex Uf-1000i, Automated Urine Particle Analyzer With Urinalysis Wam Software	K080887	FDA 510(k)	Class II	Active
Sysmex Automated Hematology Analyzer, Xt-Series	K061150	FDA 510(k)	Class II	Active
Sysmex Model Uf1000i	K070910	FDA 510(k)	Class II	Active
Sysmex XR-Series (XR-20) Automated Hematology Analyzer	K251371	FDA 510(k)	Class II	Active
Sysmex Uf-100i Automated Urine Cell Analyzer	K053135	FDA 510(k)	Class II	Active
Sysmex XR-Series (XR-10) Automated Hematology Analyzer	K250943	FDA 510(k)	Class II	Active
Sysmex Uf-500i Automated Urine Particle Analyzer	K083002	FDA 510(k)	Class II	Active
Sysmex Model Xe-2100dc Automated Hematology Analyzer	K051459	FDA 510(k)	Class II	Active
Sysmex Automated Hematology Analyzer, Xe-2100 Series (xe-2100, Xe-2100l)	K040073	FDA 510(k)	Class II	Active
Ret-He Parameter On The Sysmex Model Xe-2100 Automated Hematology Analyzer	K050589	FDA 510(k)	Class II	Active
Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control	K160541	FDA 510(k)	Class II	Active

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FDA Recalls (16)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Dec 15, 2025	Z-1136-2026	—	open, classified	Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift.
Jan 6, 2025	Z-1113-2025	—	open, classified	Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omission of the probe wash step during antibody pipetting on the PS-10 Sample Preparation System.
Jul 6, 2020	Z-2687-2020	—	terminated	Insufficient amount of antibody without an error message or alarm
Mar 9, 2020	Z-1703-2020	—	terminated	Software mismatch-When the software versions between the SP-50 and CF-70 are not matched, and an error condition occurs requiring the operator to open the cover door of the CF-70 to remove slides or slide magazines from the CF-70, the operation of the CF-70 does not halt.
Jan 21, 2020	Z-1717-2020	—	terminated	When excessive amounts of urine spills on the rack transport track and reaches the electrical components of the CV-11 conveyor, there is a potential for smoke and/or sparks which may present a combustion hazard.
Jul 27, 2018	Z-2953-2018	—	terminated	The fluorescent platelet counts (PLT-F) and immature platelet fraction (IPF) values can be falsely low when using affected lots of Fluorocell PLT.
Sep 8, 2017	Z-0045-2018	—	completed	There is potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%, #) results obtained using the lots listed above may exhibit lower than actual PLT-F and IPF values. The issue may be recognized by a large discrepancy between the impedance platelet (PLT-I) result and the PLT-F result. In most cases, the falsely decreased PLT-F results display a PLT Abn Scattergram message with an asterisk beside the result or an Action Message: Difference between PLT and PLT- F. Check the results. These are indicators of unreliable data. In rare instances, platelet flags may be absent. The PLT-I results are unaffected.
Mar 23, 2017	Z-2034-2017	—	terminated	Reported customer complaints of automated hematology analyzers catching fire due to misalignment of an internal protective sheet that shields electronic components from salty reagents. Build-up of salt deposits on unprotected electronic components may combust due to heat generated by electronics when instrument cycles. Completed CAPA identified the root cause as supplier providing defective component (sensor ready valve) and the misalignment of the electronic protective shield during manufacturing of the device.
Jul 1, 2016	Z-2770-2016	—	terminated	There is a potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%) results performed using the recalled lots may exhibit lower than expected PLT-F and IPF values. The issue may be recognized by a large discrepancy between the Impedance platelet (PLT-I) value and a false low PLT-F value. In most cases, the falsely decreased PLT-F results displayed a "PLT Abn Scattergram" message with asterisks beside the results indicating the data is unreliable. In rare instances, platelet flags may be absent. The PLT-I counts are unaffected. The PLT-F is a reflex test used to confirm PLT-I results due to flagging or low values. As such, the likely impact to patient results is low. Affected results display a discrepancy between the PLT-I and PLT-F, with lower than expected PLT-F results that do not match the patient's clinical picture.
May 15, 2013	Z-0100-2014	—	terminated	The data printed on the thermal printer may omit a digit or decimal point in the results or sample identification number.
Mar 31, 2013	Z-0949-2014	—	terminated	The current Century Break patch did not contain the same setting for the Century Break year for both the Red Hat Linux and GUI files. Due to the mismatch in file settings, the software could not properly calculate a purge date for the database files based on the customer data retention setting in the application. This resulted in the database files meeting its maximum capacity and causing system p
Jun 1, 2012	Z-0254-2013	—	terminated	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.
Jun 1, 2012	Z-0256-2013	—	terminated	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.
Jun 1, 2012	Z-0255-2013	—	terminated	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.
Apr 11, 2011	Z-3063-2011	—	terminated	The affected lots of Stromatolyser-IM lysing reagent were found to be contaminated with Pseudomonas bacteria, which resulted in rising IMI channel background counts, increased false "Platelet Clump" flags and a strong sulfur-like odor when used on the XE-2100, XE-2100L and XE-5000 analyzers.
Jun 23, 2009	Z-2797-2011	—	terminated	The affected lots of Stromatolyser-IM lysing reagent was found to be contaminated with Pseudomonas bacteria, which resulted in rising IMI channel background counts, increased false "Platelet Clump" flags and a strong sulfur-like odor when used on the XE-2100, XE-2100L and XE-5000 analyzers.