Sysmex America, Inc.
Sysmex America, Inc. holds FDA 510(k) medical device clearances, first cleared 2003, most recent 2026, with 14 FDA device recalls on record.
Top product codes for Sysmex America, Inc.
FDA recalls by Sysmex America, Inc.
10 most recent of 14- 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
- 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.
- 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.
- 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.
- Z-1717-2020 — Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers.
- 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.
- 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
- Z-2034-2017 — Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan
- 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
- 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).
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Sysmex America, Inc.
- K253212 — XR-Series (XR-10, XR-20) Automated Hematology Analyzers
- K250943 — Sysmex XR-Series (XR-10) Automated Hematology Analyzer
- K251371 — Sysmex XR-Series (XR-20) Automated Hematology Analyzer
- K250965 — Automated Blood Coagulation Analyzer CN-Series (CN-6000)
- K230887 — Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer
- K210346 — Sysmex XW-100 Automated Hematology Analyzer
- K182389 — Sysmex XN-L Automated Hematology Analyzer
- K182062 — Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device
- K171883 — Sysmex UF-5000 Fully Automated Urine Particle Analyzer
- K172604 — XW-100 Automated Hematology Analyzer for CLIA Waived Use
- K160538 — Sysmex XN-L Automated Hematology Analyzer
- K160541 — Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control
- K143577 — XW-100 Automated Hematology Analyzer, XW QC CHECK
- K141681 — SYSMEX XN SERIES
- K112605 — SYSMEX XN-SERIES
- K091313 — SYSMEX MODEL XT-4000I
- K083002 — SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER
- K081890 — SYSMEX XT-SERIES IG PARAMETER,SYSMEX XT-SERIES RET-HE PARAMETER
- K081610 — SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER
- K080887 — SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE
- K071967 — SYSMEX XE-5000
- K070910 — SYSMEX MODEL UF1000I
- K061150 — SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XT-SERIES
- K060656 — SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIES
- K053135 — SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER
- K051459 — SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER
- K051199 — IPF (IMMATURE PLATELET FRACTION) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER
- K050589 — RET-HE PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER
- K040073 — SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L)
- K032677 — SYSMEX POCH-100I
- K032039 — IMMATURE GRANULOCYTE (IG) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER
Data sourced from openFDA. This site is unofficial and independent of the FDA.