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Sysmex America, Inc. Recalls

8 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Sysmex America, Inc..

8Total Recalls
2Critical
28,087Units Affected
Jul 6, 2020Most Recent
All Recalls

Every Sysmex America, Inc. Recall

Sorted by most recent. Click any recall for full details.

8 recalls
High RiskFDA
Sysmex America, Inc.
Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usage: is a fully automated, user configurable, open system int...
Medical Devices·8 affected·Jul 6, 2020
High RiskFDA
Sysmex America, Inc.
The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained blood smears from SP-50, sele...
Medical Devices·93 affected·Mar 9, 2020
CriticalFDA
Sysmex America, Inc.
Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers.
Medical Devices·40 affected·Jan 21, 2020
High RiskFDA
Sysmex America, Inc.
Sysmex Fluorocell(R) PLT Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sys...
Medical Devices·23,239 affected·Sep 8, 2017
CriticalFDA
Sysmex America Inc
Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan
Medical Devices·3,682 affected·Mar 23, 2017
High RiskFDA
Sysmex America Inc
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...
Diagnostic Devices·193 affected·May 15, 2013
High RiskFDA
Sysmex America, Inc.
Sysmex XE-2100C Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, On...
Diagnostic Devices·69 affected·Jun 1, 2012
High RiskFDA
Sysmex America, Inc.
Sysmex XE-5000 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One...
Diagnostic Devices·763 affected·Jun 1, 2012