Sysmex America, Inc.
Medical device manufacturer in Lincolnshire, IL.
31510(k) clearances
0PMA approvals
16recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K253212 | XR-Series (XR-10, XR-20) Automated Hematology AnalyzersGKZ · Traditional | 05/27/2026SE |
| K251371 | Sysmex XR-Series (XR-20) Automated Hematology AnalyzerGKZ · Traditional | 06/25/2025SE |
| K250943 | Sysmex XR-Series (XR-10) Automated Hematology AnalyzerGKZ · Traditional | 06/25/2025SE |
| K250965 | Automated Blood Coagulation Analyzer CN-Series (CN-6000)JPA · Traditional | 06/02/2025SE |
| K230887 | Sysmex XQ-Series (XQ-320) Automated Hematology AnalyzerGKZ · Traditional | 12/21/2023SE |
| K210346 | Sysmex XW-100 Automated Hematology AnalyzerGKZ · Dual Track | 11/08/2022SE |
| K182389 | Sysmex XN-L Automated Hematology AnalyzerGKZ · Traditional | 01/25/2019SE |
| K182062 | Sysmex UD-10, Fully Automated Urine Particle Digital Imaging DeviceJOY · Traditional | 10/30/2018SE |
| K171883 | Sysmex UF-5000 Fully Automated Urine Particle AnalyzerLKM · Traditional | 04/23/2018SE |
| K172604 | XW-100 Automated Hematology Analyzer for CLIA Waived UseGKZ · Dual Track | 11/06/2017SE |
| K160538 | Sysmex XN-L Automated Hematology AnalyzerGKZ · Traditional | 12/22/2016SE |
| K160541 | Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator…JLW · Traditional | 10/21/2016SE |
| K143577 | XW-100 Automated Hematology Analyzer, XW QC CHECKGKZ · Traditional | 10/12/2015SE |
| K141681 | Sysmex XN SeriesGKZ · Traditional | 12/05/2014SE |
| K112605 | Sysmex Xn-SeriesGKZ · Traditional | 10/19/2012SE |
| K091313 | Sysmex Model XT-4000IGKZ · Traditional | 03/30/2010SE |
| K083002 | Sysmex UF-500I Automated Urine Particle AnalyzerLKM · Special | 02/03/2009SE |
| K081890 | Sysmex Xt-Series Ig Parameter,Sysmex Xt-Series Ret-He ParameterGKZ · Traditional | 10/10/2008SE |
| K081610 | Sysmex Model XS-1000IC Automated Hematology AnalyzerGKZ · Traditional | 08/29/2008SE |
| K080887 | Sysmex UF-1000I, Automated Urine Particle Analyzer with Urinalysis Wam SoftwareLKM · Special | 05/02/2008SE |
| K071967 | Sysmex XE-5000GKZ · Traditional | 11/20/2007SE |
| K070910 | Sysmex Model UF1000ILKM · Traditional | 05/25/2007SE |
| K061150 | Sysmex Automated Hematology Analyzer, Xt-SeriesGKZ · Traditional | 07/06/2006SE |
| K060656 | Sysmex Automated Hematology Analyzer Models XS SeriesGKZ · Traditional | 05/10/2006SE |
| K053135 | Sysmex UF-100I Automated Urine Cell AnalyzerLKM · Traditional | 01/04/2006SE |
| K051459 | Sysmex Model XE-2100DC Automated Hematology AnalyzerGKZ · Traditional | 09/23/2005SE |
| K051199 | Ipf (Immature Platelet Fraction) Parameter on the Sysmex Model XE-2100 Automated…GKZ · Traditional | 08/08/2005SE |
| K050589 | Ret-He Parameter on the Sysmex Model XE-2100 Automated Hematology AnalyzerGKZ · Traditional | 05/04/2005SE |
| K040073 | Sysmex Automated Hematology Analyzer, XE-2100 Series (XE-2100, XE-2100L)GKZ · Traditional | 03/18/2004SE |
| K032677 | Sysmex POCH-100IGKL · Traditional | 02/11/2004SE |
| K032039 | Immature Granulocyte (Ig) Parameter on the Sysmex Model XE-2100 Automated Hematology…GKZ · Traditional | 09/08/2003SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1136-2026 Class II | TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes…Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing… | 12/15/2025Open, Classified |
| Z-1113-2025 Class II | Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog…Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omission of the… | 01/06/2025Open, Classified |
| Z-2687-2020 Class II | Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usage: is a…Insufficient amount of antibody without an error message or alarm | 07/06/2020Terminated |
| Z-1703-2020 Class II | The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines…Software mismatch-When the software versions between the SP-50 and CF-70 are not matched, and an error… | 03/09/2020Terminated |
| Z-1717-2020 Class II | Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either…When excessive amounts of urine spills on the rack transport track and reaches the electrical components of… | 01/21/2020Terminated |
| Z-2953-2018 Class II | Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.A. by Sysmex…The fluorescent platelet counts (PLT-F) and immature platelet fraction (IPF) values can be falsely low when… | 07/27/2018Terminated |
| Z-0045-2018 Class II | Sysmex Fluorocell(R) PLT Fluorocell PLT is used to stain platelets in a diluted blood…There is potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%, #) results… | 09/08/2017Completed |
| Z-2034-2017 Class II | Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1…Reported customer complaints of automated hematology analyzers catching fire due to misalignment of an… | 03/23/2017Terminated |
| Z-2770-2016 Class II | Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain platelets in a…There is a potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%) results… | 07/01/2016Terminated |
| Z-0100-2014 Class II | pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.…The data printed on the thermal printer may omit a digit or decimal point in the results or sample… | 05/15/2013Terminated |
| Z-0949-2014 Class II | The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic…The current Century Break patch did not contain the same setting for the Century Break year for both the Red… | 03/31/2013Terminated |
| Z-0256-2013 Class II | Sysmex XE-2100C Automated Hematology System; an automated differential cell counter…There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (XT-2000i… | 06/01/2012Terminated |
| Z-0255-2013 Class II | Sysmex XE-5000 Automated Hematology System; an automated differential cell counter…There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (XT-2000i… | 06/01/2012Terminated |
| Z-0254-2013 Class II | Sysmex XE-2100 Automated Hematology System; an automated differential cell counter…There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (XT-2000i… | 06/01/2012Terminated |
| Z-3063-2011 | Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000…The affected lots of Stromatolyser-IM lysing reagent were found to be contaminated with Pseudomonas… | 04/11/2011Terminated |
| Z-2797-2011 | Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000…The affected lots of Stromatolyser-IM lysing reagent was found to be contaminated with Pseudomonas bacteria… | 06/23/2009Terminated |