Sysmex America Inc
Lincolnshire, IL
This page shows every FDA and USDA recall linked to Sysmex America Inc. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
9
Total Recalls
2013
First Recall
2026
Most Recent
TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792,...
Jan 21, 2026
· Device
Open, Classified
Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341.
Product us...
Feb 5, 2025
· Device
Open, Classified
Sysmex PS-10 Sample Preparation System
Catalog number:BQ716341 - Product Usage: is a fully automated, user co...
Jul 6, 2020
· Device
Terminated
The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained bl...
Mar 9, 2020
· Device
Terminated
Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.A. by Sysmex America, Inc., Linco...
Jul 27, 2018
· Device
Terminated
Sysmex Fluorocell(R) PLT
Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting...
Oct 16, 2017
· Device
Completed
Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kob...
Apr 14, 2017
· Device
Terminated
Fluorocell PLT reagent, Catalog #CD994563
Fluorocell PLT is used to stain platelets in a diluted blood sample...
Sep 9, 2016
· Device
Terminated
pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1...
Oct 18, 2013
· Device
Terminated