Sysmex America, Inc.

FDA Regulatory Profile

Summary

Total Recalls
14
510(k) Clearances
30
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1136-2026Class IITS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog NumberDecember 15, 2025
Z-1113-2025Class IISysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. January 6, 2025
Z-2687-2020Class IISysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usage: is a fully automateJuly 6, 2020
Z-1703-2020Class IIThe CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing March 9, 2020
Z-1717-2020Class IISysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000January 21, 2020
Z-2953-2018Class IISysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.A. by Sysmex America, IJuly 27, 2018
Z-0045-2018Class IISysmex Fluorocell(R) PLT Fluorocell PLT is used to stain platelets in a diluted blood sample for tSeptember 8, 2017
Z-2034-2017Class IISysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, ChMarch 23, 2017
Z-2770-2016Class IIFluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain platelets in a diluted blJuly 1, 2016
Z-0100-2014Class IIpocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex CorporatiMay 15, 2013
Z-0949-2014Class IIThe UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic use in urinaMarch 31, 2013
Z-0256-2013Class IISysmex XE-2100C Automated Hematology System; an automated differential cell counter; Sysmex CorporaJune 1, 2012
Z-0255-2013Class IISysmex XE-5000 Automated Hematology System; an automated differential cell counter; Sysmex CorporatJune 1, 2012
Z-0254-2013Class IISysmex XE-2100 Automated Hematology System; an automated differential cell counter; Sysmex CorporatJune 1, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerJune 25, 2025
K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerJune 25, 2025
K250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)June 2, 2025
K230887Sysmex XQ-Series (XQ-320) Automated Hematology AnalyzerDecember 21, 2023
K210346Sysmex XW-100 Automated Hematology AnalyzerNovember 8, 2022
K182389Sysmex XN-L Automated Hematology AnalyzerJanuary 25, 2019
K182062Sysmex UD-10, Fully Automated Urine Particle Digital Imaging DeviceOctober 30, 2018
K171883Sysmex UF-5000 Fully Automated Urine Particle AnalyzerApril 23, 2018
K172604XW-100 Automated Hematology Analyzer for CLIA Waived UseNovember 6, 2017
K160538Sysmex XN-L Automated Hematology AnalyzerDecember 22, 2016
K160541Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno MulOctober 21, 2016
K143577XW-100 Automated Hematology Analyzer, XW QC CHECKOctober 12, 2015
K141681SYSMEX XN SERIESDecember 5, 2014
K112605SYSMEX XN-SERIESOctober 19, 2012
K091313SYSMEX MODEL XT-4000IMarch 30, 2010
K083002SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZERFebruary 3, 2009
K081890SYSMEX XT-SERIES IG PARAMETER,SYSMEX XT-SERIES RET-HE PARAMETEROctober 10, 2008
K081610SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZERAugust 29, 2008
K080887SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWAREMay 2, 2008
K071967SYSMEX XE-5000November 20, 2007