Sysmex America, Inc.
FDA Regulatory Profile
Sysmex America, Inc. appears in FDA public data with 14 recalls, 31 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1136-2026, Class II) was initiated on December 15, 2025. Its most recent 510(k) clearance was granted on May 27, 2026.
Summary
- Total Recalls
- 14
- 510(k) Clearances
- 31
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1136-2026 | Class II | TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number | December 15, 2025 |
| Z-1113-2025 | Class II | Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. | January 6, 2025 |
| Z-2687-2020 | Class II | Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usage: is a fully automate | July 6, 2020 |
| Z-1703-2020 | Class II | The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing | March 9, 2020 |
| Z-1717-2020 | Class II | Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 | January 21, 2020 |
| Z-2953-2018 | Class II | Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.A. by Sysmex America, I | July 27, 2018 |
| Z-0045-2018 | Class II | Sysmex Fluorocell(R) PLT Fluorocell PLT is used to stain platelets in a diluted blood sample for t | September 8, 2017 |
| Z-2034-2017 | Class II | Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Ch | March 23, 2017 |
| Z-2770-2016 | Class II | Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain platelets in a diluted bl | July 1, 2016 |
| Z-0100-2014 | Class II | pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporati | May 15, 2013 |
| Z-0949-2014 | Class II | The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic use in urina | March 31, 2013 |
| Z-0254-2013 | Class II | Sysmex XE-2100 Automated Hematology System; an automated differential cell counter; Sysmex Corporat | June 1, 2012 |
| Z-0256-2013 | Class II | Sysmex XE-2100C Automated Hematology System; an automated differential cell counter; Sysmex Corpora | June 1, 2012 |
| Z-0255-2013 | Class II | Sysmex XE-5000 Automated Hematology System; an automated differential cell counter; Sysmex Corporat | June 1, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253212 | XR-Series (XR-10, XR-20) Automated Hematology Analyzers | May 27, 2026 |
| K251371 | Sysmex XR-Series (XR-20) Automated Hematology Analyzer | June 25, 2025 |
| K250943 | Sysmex XR-Series (XR-10) Automated Hematology Analyzer | June 25, 2025 |
| K250965 | Automated Blood Coagulation Analyzer CN-Series (CN-6000) | June 2, 2025 |
| K230887 | Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer | December 21, 2023 |
| K210346 | Sysmex XW-100 Automated Hematology Analyzer | November 8, 2022 |
| K182389 | Sysmex XN-L Automated Hematology Analyzer | January 25, 2019 |
| K182062 | Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device | October 30, 2018 |
| K171883 | Sysmex UF-5000 Fully Automated Urine Particle Analyzer | April 23, 2018 |
| K172604 | XW-100 Automated Hematology Analyzer for CLIA Waived Use | November 6, 2017 |
| K160538 | Sysmex XN-L Automated Hematology Analyzer | December 22, 2016 |
| K160541 | Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Mul | October 21, 2016 |
| K143577 | XW-100 Automated Hematology Analyzer, XW QC CHECK | October 12, 2015 |
| K141681 | SYSMEX XN SERIES | December 5, 2014 |
| K112605 | SYSMEX XN-SERIES | October 19, 2012 |
| K091313 | SYSMEX MODEL XT-4000I | March 30, 2010 |
| K083002 | SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER | February 3, 2009 |
| K081890 | SYSMEX XT-SERIES IG PARAMETER,SYSMEX XT-SERIES RET-HE PARAMETER | October 10, 2008 |
| K081610 | SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER | August 29, 2008 |
| K080887 | SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE | May 2, 2008 |