Company ยท US
Sysmex America, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2026. Name variants (Inc, Corp, punctuation) are merged.
31510(k) clearances (1 in 12 months)
16recalls (1 in 12 months)
6recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GKZ | Counter, Differential Cell | 27 |
| LKM | Counter, Urine Particle | 6 |
| KQC | Stains, Hematology | 3 |
| GGK | Products, Red-Cell Lysing Products | 2 |
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | 2 |
| PER | Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis | 2 |
| GKL | Counter, Cell, Automated (Particle Counter) | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 |
| JOY | Device, Automated Cell-Locating | 1 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 1 |
| KQO | Automated Urinalysis System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 27, 2026 | K253212 | XR-Series (XR-10, XR-20) Automated Hematology Analyzers Sysmex America, Inc. | GKZ |
| Jun 25, 2025 | K251371 | Sysmex XR-Series (XR-20) Automated Hematology Analyzer Sysmex America, Inc. | GKZ |
| Jun 25, 2025 | K250943 | Sysmex XR-Series (XR-10) Automated Hematology Analyzer Sysmex America, Inc. | GKZ |
| Jun 2, 2025 | K250965 | Automated Blood Coagulation Analyzer CN-Series (CN-6000) Sysmex America, Inc. | JPA |
| Dec 21, 2023 | K230887 | Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer Sysmex America, Inc. | GKZ |
| Nov 8, 2022 | K210346 | Sysmex XW-100 Automated Hematology Analyzer Sysmex America, Inc. | GKZ |
| Jan 25, 2019 | K182389 | Sysmex XN-L Automated Hematology Analyzer Sysmex America, Inc. | GKZ |
| Oct 30, 2018 | K182062 | Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device Sysmex America, Inc. | JOY |
| Apr 23, 2018 | K171883 | Sysmex UF-5000 Fully Automated Urine Particle Analyzer Sysmex America, Inc. | LKM |
| Nov 6, 2017 | K172604 | XW-100 Automated Hematology Analyzer for CLIA Waived Use Sysmex America, Inc. | GKZ |
| Dec 22, 2016 | K160538 | Sysmex XN-L Automated Hematology Analyzer Sysmex America, Inc. | GKZ |
| Oct 21, 2016 | K160541 | Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control Sysmex America, Inc. | JLW |
| Oct 12, 2015 | K143577 | XW-100 Automated Hematology Analyzer, XW QC CHECK Sysmex America, Inc. | GKZ |
| Dec 5, 2014 | K141681 | SYSMEX XN SERIES Sysmex America, Inc. | GKZ |
| Oct 19, 2012 | K112605 | SYSMEX XN-SERIES Sysmex America, Inc. | GKZ |
| Mar 30, 2010 | K091313 | SYSMEX MODEL XT-4000I Sysmex America, Inc. | GKZ |
| Feb 3, 2009 | K083002 | SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER Sysmex America, Inc. | LKM |
| Oct 10, 2008 | K081890 | SYSMEX XT-SERIES IG PARAMETER,SYSMEX XT-SERIES RET-HE PARAMETER Sysmex America, Inc. | GKZ |
| Aug 29, 2008 | K081610 | SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER Sysmex America, Inc. | GKZ |
| May 2, 2008 | K080887 | SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE Sysmex America, Inc. | LKM |
| Nov 20, 2007 | K071967 | SYSMEX XE-5000 Sysmex America, Inc. | GKZ |
| May 25, 2007 | K070910 | SYSMEX MODEL UF1000I Sysmex America, Inc. | LKM |
| Jul 6, 2006 | K061150 | SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XT-SERIES Sysmex America, Inc. | GKZ |
| May 10, 2006 | K060656 | SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIES Sysmex America, Inc. | GKZ |
| Jan 4, 2006 | K053135 | SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER Sysmex America, Inc. | LKM |
| Sep 23, 2005 | K051459 | SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER Sysmex America, Inc. | GKZ |
| Aug 8, 2005 | K051199 | IPF (IMMATURE PLATELET FRACTION) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER Sysmex America, Inc. | GKZ |
| May 4, 2005 | K050589 | RET-HE PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER Sysmex America, Inc. | GKZ |
| Mar 18, 2004 | K040073 | SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L) Sysmex America, Inc. | GKZ |
| Feb 11, 2004 | K032677 | SYSMEX POCH-100I Sysmex America, Inc. | GKL |
| Sep 8, 2003 | K032039 | IMMATURE GRANULOCYTE (IG) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER Sysmex America, Inc. | GKZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 21, 2026 | Sysmex America, Inc. TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17 Open, Classified |
LXG | None listed |
| Feb 5, 2025 | Sysmex America, Inc. 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 cytom Open, Classified |
PER | None listed |
| Jul 6, 2020 | Sysmex America, Inc. 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 Terminated |
PER | None listed |
| Mar 9, 2020 | Sysmex America, Inc. 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 t Terminated |
LXG | None listed |
| Jan 21, 2020 | Sysmex America, Inc. Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers. Terminated |
KQO | None listed |
| Jul 27, 2018 | Sysmex America, Inc. 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 Terminated |
KQC | None listed |
| Oct 16, 2017 | Sysmex America, Inc. 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 Completed |
KQC | None listed |
| Apr 14, 2017 | Sysmex America Inc Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan Terminated |
GKZ | K112605 K141681 |
| Sep 9, 2016 | Sysmex America Inc 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 Terminated |
KQC | None listed |
| Feb 10, 2014 | Sysmex America, Inc. 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 Terminated |
LKM | K080887 |
| Oct 18, 2013 | Sysmex America Inc 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. W Terminated |
GKZ | K032677 |
| Nov 6, 2012 | Sysmex America, Inc. 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 #053-23 Terminated |
GKZ | K051457 |
| Nov 6, 2012 | Sysmex America, Inc. 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 #063-759 Terminated |
GKZ | K071967 |
| Nov 6, 2012 | Sysmex America, Inc. 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 #983-134 Terminated |
GKZ | K992875 |
| Aug 23, 2011 | Sysmex America, Inc. 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 (cardboa Terminated |
GGK | None listed |
| Jul 13, 2011 | Sysmex America, Inc. 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 (cardboa Terminated |
GGK | None listed |