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Sysmex America, Inc.

12 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Cata recall (Z-1136-2026)Sysmex America, Inc.2026-01-21
Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number recall (Z-1113-2025)Sysmex America, Inc.2025-02-05
Sysmex Fluorocell(R) PLT Fluorocell PLT is used to stain platelets in a diluted blood samp recall (Z-0045-2018)Sysmex America, Inc.2017-10-16
Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaig recall (Z-2034-2017)Sysmex America Inc2017-04-14
Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain platelets in a d recall (Z-2770-2016)Sysmex America Inc2016-09-09
The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic us recall (Z-0949-2014)Sysmex America, Inc.2014-02-10
pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex recall (Z-0100-2014)Sysmex America Inc2013-10-18
Sysmex XE-2100 Automated Hematology System; an automated differential cell counter; Sysmex recall (Z-0254-2013)Sysmex America, Inc.2012-11-06
Sysmex XE-5000 Automated Hematology System; an automated differential cell counter; Sysmex recall (Z-0255-2013)Sysmex America, Inc.2012-11-06
Sysmex XE-2100C Automated Hematology System; an automated differential cell counter; Sysme recall (Z-0256-2013)Sysmex America, Inc.2012-11-06
Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000 Se recall (Z-3063-2011)Sysmex America, Inc.2011-08-23
Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000 Se recall (Z-2797-2011)Sysmex America, Inc.2011-07-13

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Every clearance here is in the API, with alerts when new ones post.