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Sysmex America

Diagnostics maker in United States, part of Sysmex Corporation. FDA records under 3 spellings of its name, each linked to the record.

  • 510(k) clearances: 31
  • Device recalls: 14

Records by Year

Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date

Latest Records

Newest first across sources; each opens the record
DateRecordSource
May 27, 2026XR-Series (XR-10, XR-20) Automated Hematology AnalyzersK253212 · GKZ510(k) clearances
Jun 25, 2025Sysmex XR-Series (XR-20) Automated Hematology AnalyzerK251371 · GKZ510(k) clearances
Jun 25, 2025Sysmex XR-Series (XR-10) Automated Hematology AnalyzerK250943 · GKZ510(k) clearances
Jun 2, 2025Automated Blood Coagulation Analyzer CN-Series (CN-6000)K250965 · JPA510(k) clearances
Dec 21, 2023Sysmex XQ-Series (XQ-320) Automated Hematology AnalyzerK230887 · GKZ510(k) clearances
Nov 8, 2022Sysmex XW-100 Automated Hematology AnalyzerK210346 · GKZ510(k) clearances
Jan 25, 2019Sysmex XN-L Automated Hematology AnalyzerK182389 · GKZ510(k) clearances
Oct 30, 2018Sysmex UD-10, Fully Automated Urine Particle Digital Imaging DeviceK182062 · JOY510(k) clearances
Mar 23, 2017Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 JapanClass II · Reported customer complaints of automated hematology analyzers catching fire due to misalignment of an internal protectiDevice recalls
Jul 1, 2016Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of plateletsClass II · There is a potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%) results performed using theDevice recalls
May 15, 2013pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1 Wakinohama-Kaigandori, Chuo-kuClass II · The data printed on the thermal printer may omit a digit or decimal point in the results or sample identification numberDevice recalls

Names and Identifiers

Appears as
Sysmex America, Inc.Sysmex America Inc

Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.