Data / Medical devices / United States / Sysmex America, Inc.
Sysmex America, Inc.: FDA-registered device maker in Lincolnshire, IL, United States, 32 510(k) clearances
Sysmex America, Inc. is registered with the FDA (registration 3009711478) in Lincolnshire, IL, United States. It lists 30 device types. The FDA files 32 510(k) clearances under its listings, the newest dated June 25, 2025. 9 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3009711478
- Address
- 577 Aptakisic Rd, Lincolnshire, IL, United States, 60069
- Owner or operator
- SYSMEX CORPORATION (9014170)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- May 6, 1998
- Registered through
- 2027
- Brand names listed
- AUTOMATED HEMATOLOGY ANALYZER XW-100, AlphaN-SPSU, AlphaN-XESU, Automated Blood Coagulation Analyzer CN-3000, Automated Blood Coagulation Analyzer CN-6000, Automated Immunoassay System HISCL-800, BT-50, Barcode Terminal (BT-40) and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 25, 2025 | K251371 | Sysmex XR-Series (XR-20) Automated Hematology Analyzer | GKZ | Substantially Equivalent | Sysmex America, Inc. | accessdata.fda.gov |
| June 25, 2025 | K250943 | Sysmex XR-Series (XR-10) Automated Hematology Analyzer | GKZ | Substantially Equivalent | Sysmex America, Inc. | accessdata.fda.gov |
| June 2, 2025 | K250965 | Automated Blood Coagulation Analyzer CN-Series (CN-6000) | JPA | Substantially Equivalent | Sysmex America, Inc. | accessdata.fda.gov |
| December 21, 2023 | K230887 | Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer | GKZ | Substantially Equivalent | Sysmex America, Inc. | accessdata.fda.gov |
| November 8, 2022 | K210346 | Sysmex XW-100 Automated Hematology Analyzer | GKZ | Substantially Equivalent | Sysmex America, Inc. | accessdata.fda.gov |
| January 25, 2019 | K182389 | Sysmex XN-L Automated Hematology Analyzer | GKZ | Substantially Equivalent | Sysmex America, Inc. | accessdata.fda.gov |
| October 30, 2018 | K182062 | Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device | JOY | Substantially Equivalent | Sysmex America, Inc. | accessdata.fda.gov |
| April 23, 2018 | K171883 | Sysmex UF-5000 Fully Automated Urine Particle Analyzer | LKM | Substantially Equivalent | Sysmex America, Inc. | accessdata.fda.gov |
| November 6, 2017 | K172604 | XW-100 Automated Hematology Analyzer for CLIA Waived Use | GKZ | Substantially Equivalent | Sysmex America, Inc. | accessdata.fda.gov |
| December 22, 2016 | K160590 | XN CHECK | JPK | Substantially Equivalent | Streck | accessdata.fda.gov |
| December 22, 2016 | K160586 | XN-L CHECK | JPK | Substantially Equivalent | Streck | accessdata.fda.gov |
| December 22, 2016 | K160538 | Sysmex XN-L Automated Hematology Analyzer | GKZ | Substantially Equivalent | Sysmex America, Inc. | accessdata.fda.gov |
| October 21, 2016 | K160541 | Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control | JLW | Substantially Equivalent | Sysmex America, Inc. | accessdata.fda.gov |
| January 26, 2016 | K151259 | Sysmex Automated Blood Coagulation Analyzer CS-2100i | JPA | Substantially Equivalent | Siemens Healthcare Diagnostics Products GmbH | accessdata.fda.gov |
| January 11, 2016 | K150678 | Sysmex Automated Blood Coagulation Analyzer CS-5100 | JPA | Substantially Equivalent | Siemens Healthcare Diagnostic Products GmbH | accessdata.fda.gov |
| October 12, 2015 | K143577 | XW-100 Automated Hematology Analyzer, XW QC CHECK | GKZ | Substantially Equivalent | Sysmex America, Inc. | accessdata.fda.gov |
| December 5, 2014 | K141681 | SYSMEX XN SERIES | GKZ | Substantially Equivalent | Sysmex America, Inc. | accessdata.fda.gov |
| October 22, 2012 | K120747 | XN CAL PF | KRX | Substantially Equivalent | Streck | accessdata.fda.gov |
| October 19, 2012 | K120745 | XN CAL | KRX | Substantially Equivalent | Streck | accessdata.fda.gov |
| October 19, 2012 | K120744 | XN CHECK BF | JPK | Substantially Equivalent | Streck | accessdata.fda.gov |
| October 19, 2012 | K120742 | XN CHECK | JPK | Substantially Equivalent | Streck | accessdata.fda.gov |
| October 19, 2012 | K112605 | SYSMEX XN-SERIES | GKZ | Substantially Equivalent | Sysmex America, Inc. | accessdata.fda.gov |
| February 3, 2009 | K083200 | X-CAL | KRX | Substantially Equivalent | Streck | accessdata.fda.gov |
| December 14, 2006 | K063218 | E-CHECK (XE) | JPK | Substantially Equivalent | Streck | accessdata.fda.gov |
| February 11, 2004 | K032677 | SYSMEX POCH-100I | GKL | Substantially Equivalent | Sysmex America, Inc. | accessdata.fda.gov |
| September 8, 2003 | K031377 | SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560 | GKP | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| July 20, 2001 | K011235 | SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500 | JPA | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| January 14, 2000 | K994388 | XE CHECK | GLQ | Substantially Equivalent | Streck Laboratories, Inc. | accessdata.fda.gov |
| August 14, 1998 | K981761 | SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER | GKL | Substantially Equivalent | Sysmex Corp. | accessdata.fda.gov |
| April 3, 1996 | K960557 | CALIBRATION VERIFICATION ASSESSMENT (CVA) | JPK | Substantially Equivalent | Streck Laboratories, Inc. | accessdata.fda.gov |
| December 15, 1994 | K943268 | SCS-1000 (SYSMEX CALIBRATOR SYSTEM) | KSA | Substantially Equivalent | Streck Laboratories, Inc. | accessdata.fda.gov |
| October 10, 1985 | K852992 | PARA CHECK (AKA EIGHT CHECK-C) | JPK | Substantially Equivalent | Streck Laboratories, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 15, 2025 | 98213 | Class II | Ongoing | TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17 | Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift. | accessdata.fda.gov |
| January 6, 2025 | 96107 | Class II | Ongoing | 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. | Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omission of the probe wash step during antibody pipetting on the PS-10 Sample Preparation System. | accessdata.fda.gov |
| July 6, 2020 | 85959 | Class II | Terminated | 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. | Insufficient amount of antibody without an error message or alarm | accessdata.fda.gov |
| March 9, 2020 | 85254 | Class II | Terminated | The CF-70 instrument (product code: LXG; Regulation Number: ) receives magazines containing stained blood smears from SP-50, selects only smears that require analysis, and transports them to the DI-60 for further analysi | Software mismatch-When the software versions between the SP-50 and CF-70 are not matched, and an error condition occurs requiring the operator to open the cover door of the CF-70 to remove slides or slide magazines from the CF-70, the operation of the CF-70 does not halt. | accessdata.fda.gov |
| July 27, 2018 | 80716 | Class II | Terminated | 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 w | The fluorescent platelet counts (PLT-F) and immature platelet fraction (IPF) values can be falsely low when using affected lots of Fluorocell PLT. | accessdata.fda.gov |
| September 8, 2017 | 78134 | Class II | Completed | 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 | There is potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%, #) results obtained using the lots listed above may exhibit lower than actual PLT-F and IPF values. The issue may be recognized by a large discrepancy between the impedance platelet (PLT-I) result and the PLT-F result. In most cases, the falsely decreased PLT-F results | accessdata.fda.gov |
| March 23, 2017 | 76828 | Class II | Terminated | Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe Japan | Reported customer complaints of automated hematology analyzers catching fire due to misalignment of an internal protective sheet that shields electronic components from salty reagents. Build-up of salt deposits on unprotected electronic components may combust due to heat generated by electronics when instrument cycles. Completed CAPA identified the root caus | accessdata.fda.gov |
| July 1, 2016 | 74654 | Class II | Terminated | 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 | There is a potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%) results performed using the recalled lots may exhibit lower than expected PLT-F and IPF values. The issue may be recognized by a large discrepancy between the Impedance platelet (PLT-I) value and a false low PLT-F value. In most cases, the falsely decreased PLT-F res | accessdata.fda.gov |
| May 15, 2013 | 65722 | Class II | Terminated | 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, Japan; Sysmex America, Inc; One Nelson C. White Pkwy, Mundeline, IL 6006 | The data printed on the thermal printer may omit a digit or decimal point in the results or sample identification number. | accessdata.fda.gov |
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Updated January 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.