Sysmex America, Inc.
Mundelein, IL, US
Sysmex America, Inc. appears in FDA device records in Mundelein, IL. FDA records list 31 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 16 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 31 510(k) clearances for Sysmex America, Inc. between 2003 and 2026. The busiest year on record is 2005, with 3. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2004 | 2 |
| 2005 | 3 |
| 2006 | 3 |
| 2007 | 2 |
| 2008 | 3 |
| 2009 | 1 |
| 2010 | 1 |
| 2012 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 2 |
| 2017 | 1 |
| 2018 | 2 |
| 2019 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2025 | 3 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253212 | XR-Series (XR-10, XR-20) Automated Hematology Analyzers | GKZ | Substantially Equivalent | |
| K251371 | Sysmex XR-Series (XR-20) Automated Hematology Analyzer | GKZ | Substantially Equivalent | |
| K250943 | Sysmex XR-Series (XR-10) Automated Hematology Analyzer | GKZ | Substantially Equivalent | |
| K250965 | Automated Blood Coagulation Analyzer CN-Series (CN-6000) | JPA | Substantially Equivalent | |
| K230887 | Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer | GKZ | Substantially Equivalent | |
| K210346 | Sysmex XW-100 Automated Hematology Analyzer | GKZ | Substantially Equivalent | |
| K182389 | Sysmex XN-L Automated Hematology Analyzer | GKZ | Substantially Equivalent | |
| K182062 | Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device | JOY | Substantially Equivalent | |
| K171883 | Sysmex UF-5000 Fully Automated Urine Particle Analyzer | LKM | Substantially Equivalent | |
| K172604 | XW-100 Automated Hematology Analyzer for CLIA Waived Use | GKZ | Substantially Equivalent | |
| K160538 | Sysmex XN-L Automated Hematology Analyzer | GKZ | Substantially Equivalent | |
| K160541 | Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control | JLW | Substantially Equivalent | |
| K143577 | XW-100 Automated Hematology Analyzer, XW QC CHECK | GKZ | Substantially Equivalent | |
| K141681 | SYSMEX XN SERIES | GKZ | Substantially Equivalent | |
| K112605 | SYSMEX XN-SERIES | GKZ | Substantially Equivalent | |
| K091313 | SYSMEX MODEL XT-4000I | GKZ | Substantially Equivalent | |
| K083002 | SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER | LKM | Substantially Equivalent | |
| K081890 | SYSMEX XT-SERIES IG PARAMETER,SYSMEX XT-SERIES RET-HE PARAMETER | GKZ | Substantially Equivalent | |
| K081610 | SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER | GKZ | Substantially Equivalent | |
| K080887 | SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE | LKM | Substantially Equivalent | |
| K071967 | SYSMEX XE-5000 | GKZ | Substantially Equivalent | |
| K070910 | SYSMEX MODEL UF1000I | LKM | Substantially Equivalent | |
| K061150 | SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XT-SERIES | GKZ | Substantially Equivalent | |
| K060656 | SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIES | GKZ | Substantially Equivalent | |
| K053135 | SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER | LKM | Substantially Equivalent | |
| K051459 | SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER | GKZ | Substantially Equivalent | |
| K051199 | IPF (IMMATURE PLATELET FRACTION) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER | GKZ | Substantially Equivalent | |
| K050589 | RET-HE PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER | GKZ | Substantially Equivalent | |
| K040073 | SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L) | GKZ | Substantially Equivalent | |
| K032677 | SYSMEX POCH-100I | GKL | Substantially Equivalent | |
| K032039 | IMMATURE GRANULOCYTE (IG) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER | GKZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1422681 | 1000515253 | SYSMEX AMERICA, INC. | ONE SYSMEX WAY, Mundelein, IL 60060 US | 2026 | |
| 3009495621 | 3009495621 | Sysmex America, Inc. | SAI - Multi-Purpose Building, Buffalo Grove, IL 60089 US | 2026 | |
| 3009711478 | 3009711478 | Sysmex America, Inc. | 577 Aptakisic Rd, Lincolnshire, IL 60069 US | 2026 | and 20 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- PERAutomated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
- JQPCalculator/Data Processing Module, For Clinical Use
- KRXCalibrator For Cell Indices
- KSACalibrator For Red-Cell And White-Cell Counting
- JITCalibrator, Secondary
- JIWCalibrator, Surrogate
- JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- NNIContainer, Specimen, Non-Sterile
- GJPControl, Platelet
- GKLCounter, Cell, Automated (Particle Counter)
- GKZCounter, Differential Cell
- LKMCounter, Urine Particle
- JOYDevice, Automated Cell-Locating
- GIFDiluent, Blood Cell
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- PPMGeneral Purpose Reagent
- GKPInstrument, Coagulation, Automated
- OUGMedical Device Data System
- GLEMixer, Blood Tube
- GLQMixture, Control, White-Cell And Red-Cell Indices
- JPKMixture, Hematology Quality Control
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- GGKProducts, Red-Cell Lysing Products
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- MVUReagents, Specific, Analyte
- KPASlide Stainer, Automated
- GJHStain, Reticulocyte
- JPASystem, Multipurpose For In Vitro Coagulation Studies
- JJWUrinalysis Controls (Assayed And Unassayed)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1136-2026 | TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17 | Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift. | Class II | Open, Classified | |
| Z-1113-2025 | Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product usage for automated pipetting, diluting, and specimen processing workstations for flow cytometric analysis. | 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. | Class II | Open, Classified | |
| Z-2687-2020 | Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usage: is a fully automated, user configurable, open system intended for use to prepare human specimens for subsequent analysis on flow cytometers. | Insufficient amount of antibody without an error message or alarm | Class II | Terminated | |
| Z-1703-2020 | The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained blood smears from SP-50, selects only smears that require analysis, and transports them to the DI-60 for further analysis. After completing the analysis on DI-60 the smears are placed back in magazines. | 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. | Class II | Terminated | |
| Z-1717-2020 | Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers. | 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. | Class II | Terminated | |
| Z-2953-2018 | Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.A. by Sysmex America, Inc., Lincolnshire, IL. Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers. | The fluorescent platelet counts (PLT-F) and immature platelet fraction (IPF) values can be falsely low when using affected lots of Fluorocell PLT. | Class II | Terminated | |
| Z-0045-2018 | Sysmex Fluorocell(R) PLT Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers | 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. | Class II | Completed | |
| Z-2034-2017 | Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan | 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. | Class II | Terminated | |
| Z-2770-2016 | Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers | 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. | Class II | Terminated | |
| Z-0100-2014 | pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan; Sysmex America, Inc; One Nelson C. White Pkwy, Mundeline, IL 60060, U.S.A. The Sysmex pocH-100i Automated Hematology Analyzer is an automated cell counter intended for in vitro diagnostic use in CLIA non-waived clinical laboratories (not for Point of Care use in a CLIA waived laboratory). The Complete Blood Cel (CBC) count test parameters include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV, and NEUT%/#, LYMPH %/#, MIXED %/# (EO, BSO, MONO). | The data printed on the thermal printer may omit a digit or decimal point in the results or sample identification number. | Class II | Terminated | |
| Z-0949-2014 | The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic use in urinalysis. The instrument can perform screening for abnormal samples with a high degree of accuracy, so it increases automation and efficiency in laboratories. | 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 | Class II | Terminated | |
| 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 populations found in clinical laboratories. | 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. | Class II | Terminated | |
| 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 found in clinical laboratories. The XE-5000 performs analyses using the following methods: RF/DC Detection Method, Sheath Row DC Detection Method, and Flow Cytometry Methods using a Semiconductor Laser. Particle characterization and identification is based on detection of forward scatter, fluorescence and adaptive cluster analysis. Using the same reagents as the XE-2100, the XE-5000 automatically classifies cells from blood and body fluids and carries out all processes automatically from aspiration of the sample to outputting the results. | 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. | Class II | Terminated | |
| 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 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. | 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. | Class II | Terminated | |
| Z-3063-2011 | Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000 Series Sysmex Automated Hematology Analyzers; the reagent solution is supplied in a 10-liter cubetainer (cardboard cube with a 10-liter plastic liner); Sysmex America, Inc., Mundelein, IL 60060; catalog number SIM-220A. The STROMATOLYSER-IM lysing reagent is used to destroy red blood cells to aid in the counting and characterization on immature white blood cells. This reagent is used on the Sysmex XE-Series and SE Series hematology analyzers. | 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. | Terminated | ||
| Z-2797-2011 | Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000 Series Sysmex Automated Hematology Analyzers; the reagent solution is supplied in a 10-liter cubetainer (cardboard cube with a 10-liter plastic liner); Sysmex America, Inc., Mundelein, IL 60060; catalog number SIM-220A. The product is a lytic reagent used to lyse (destroy) red blood cells for hemoglobin determinations or aid in the counting of white blood cells. | 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. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain