Sysmex America recalls

Sysmex America appears in 14 official U.S. recall notices indexed by RecallRadar, most recently on 2026-01-28.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00…
  FDA Device · Class II · 2026-01-28 · Sysmex America
• Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341
  FDA Device · Class II · 2025-02-12 · Sysmex America
• Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usage: is a fully automated, user configurable, open system intend…
  FDA Device · Class II · 2020-07-29 · Sysmex America
• Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers
  FDA Device · Class II · 2020-04-22 · Sysmex America
• The CF-70 instrument (product code: LXG
  FDA Device · Class II · 2020-04-22 · Sysmex America
• Sysmex XN-Series Fluorocell PLT, Catalog #CD994563
  FDA Device · Class II · 2018-09-05 · Sysmex America
• Sysmex Fluorocell(R) PLT Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex…
  FDA Device · Class II · 2017-11-01 · Sysmex America
• Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan
  FDA Device · Class II · 2017-05-10 · Sysmex America
• Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets…
  FDA Device · Class II · 2016-09-21 · Sysmex America
• The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic use in urinalysis
  FDA Device · Class II · 2014-02-19 · Sysmex America
• pocH-100i
  FDA Device · Class II · 2013-11-06 · Sysmex America
• Sysmex XE-2100 Automated Hematology System
  FDA Device · Class II · 2012-11-14 · Sysmex America
• Sysmex XE-5000 Automated Hematology System
  FDA Device · Class II · 2012-11-14 · Sysmex America
• Sysmex XE-2100C Automated Hematology System
  FDA Device · Class II · 2012-11-14 · Sysmex America