PlainRecalls

Sysmex America, Inc.

Compiled from official public sources by the publisher.

14 recalls on record · Latest: Jan 28, 2026

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Agency notice ledger

Federal filing book Sysmex America, Inc. LIGHT-BOOK · SINGLE-AGENCY

#1,132 of 14,151 · 14 notices · 0.013% archive

  • BOOK 14 notices
  • RANK #1,132 of 14,151
  • SHARE 0.013% archive
  • AGENCY FDA Devices (14)
  • CAT medical devices
  • CATS 1 category
  • LATEST Jan 28, 2026
  • PHOTO Actavis Elizabeth LLC

Nearest notice-volume peer: Actavis Elizabeth LLC (0 notice gap)

Sysmex America, Inc. accounts for about 0.013% of the 104,423-notice archive on 14 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Sysmex America, Inc.'s standing among 14,151 recalling firms

Sysmex America, Inc. ranks 1,132nd of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Sysmex America, Inc. vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

14 1132nd of 14151 higher than 13,008 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Sysmex America, Inc. in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Sysmex America, Inc. holds about 0.013% of archive notices alongside 14 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Jan 28, 2026

TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17
FDA Devices Moderate Feb 12, 2025

Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product usage for automated pipetting, diluting, and specimen processing workstations for flow cytometric analysis.
FDA Devices Moderate Jul 29, 2020

Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usage: is a fully automated, user configurable, open system intended for use to prepare human specimens for subsequent analysis on flow cytometers.
FDA Devices Moderate Apr 22, 2020

Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers.
FDA Devices Moderate Apr 22, 2020

The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained blood smears from SP-50, selects only smears that require analysis, and transports them to the DI-60 for further analysis. After completing the analysis on DI-60 the smears are placed back in magazines.
FDA Devices Moderate Sep 5, 2018

Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.A. by Sysmex America, Inc., Lincolnshire, IL. Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers.
FDA Devices Moderate Nov 1, 2017

Sysmex Fluorocell(R) PLT Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers
FDA Devices Moderate May 10, 2017

Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan
FDA Devices Moderate Sep 21, 2016

Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers
FDA Devices Moderate Feb 19, 2014

The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic use in urinalysis. The instrument can perform screening for abnormal samples with a high degree of accuracy, so it increases automation and efficiency in laboratories.
FDA Devices Moderate Nov 6, 2013

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-ku, Kobe 651-0073, Japan; Sysmex America, Inc; One Nelson C. White Pkwy, Mundeline, IL 60060, U.S.A. The Sysmex pocH-100i Automated Hematology Analyzer is an automated cell counter intended for in vitro diagnostic use in CLIA non-waived clinical laboratories (not for Point of Care use in a CLIA waived laboratory). The Complete Blood Cel (CBC) count test par
FDA Devices Moderate Nov 14, 2012

Sysmex XE-2100C Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #053-2311-4 The Sysmex XE-2100C is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.
FDA Devices Moderate Nov 14, 2012

Sysmex XE-5000 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #063-7591-7 The Sysmex XE-5000 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XE-5000 performs analyses using the following methods: RF/DC Detection Method, Sheath Row DC Detection Method, and Flow Cytometry Methods usi
FDA Devices Moderate Nov 14, 2012

Sysmex XE-2100 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #983-1341-1 The Sysmex XE-2100 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XE-2100 performs hematology analyses according to the RF/DC detection method, HydroDynamic Focusing (DC Detection), flow cytometry method (

Sysmex America, Inc. holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (14 here — thin-book).

Actavis Elizabeth LLC 14 Albertsons Companies, Inc. 14 Allergan Sales, LLC 14 American Contract Systems 14 Aurolife Pharma, LLC 14

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

American Contract Systems 14 Bd Switzerland Sarl 14 Biomet Spine, LLC 14 Cardiac Assist, Inc 14

Frequently Asked Questions

How many federal recall notices name Sysmex America, Inc.? ▼
PlainRecalls indexes 14 distinct federal recall events naming Sysmex America, Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Sysmex America, Inc. sit among other recalling firms? ▼
Sysmex America, Inc. ranks #1,132 of 14,151 by distinct recall-event count among 14,151 firms in this archive (92nd percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Sysmex America, Inc.'s notices? ▼
FDA Devices accounts for 14 of this firm's 14 indexed notices.
What product category dominates Sysmex America, Inc.'s filing book? ▼
Filings for Sysmex America, Inc. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Sysmex America, Inc.: 14 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Sysmex America, Inc.; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026