The Recall Desk

Manufacturer

Sysmex America, Inc.

14 recalls in our database name Sysmex America, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
14
Critical
0
Severe
2
Most recent
2026-01-28

Of the 14 recalls from Sysmex America, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (14%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–14 of 14

  • ModerateFDA (Devices)·Z-1136-2026·2026-01-28

    Laboratory tube sorters recalled over a lift that may drop unexpectedly

    Sysmex America is recalling 44 TS-10/TS-10H Tube Sorters because the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement.

    Product
    TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1113-2025·2025-02-12

    Sysmex PS-10 Sample Preparation System Recalled for False Test Results

    Sysmex PS-10 Sample Preparation Systems may produce false test results due to sporadic omission of the probe wash step during antibody pipetting. Thirty-two units have been recalled nationwide.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2687-2020·2020-07-29

    Sysmex PS-10 Sample Preparation System Recalled for Insufficient Antibody

    Sysmex America, Inc. is recalling eight PS-10 Sample Preparation Systems because they may contain insufficient antibody without triggering an error message or alarm.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1717-2020·2020-04-22

    Sysmex CV-11 Sample Unit Recalled for Combustion Hazard

    Sysmex America is recalling 40 CV-11 Sample Units because urine spills on the transport track can reach electrical components, creating a potential for smoke, sparks, and combustion.

    Product
    Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1703-2020·2020-04-22

    Sysmex CF-70 Blood Smear Transporter Recalled for Software Mismatch Hazard

    Sysmex America is recalling 93 CF-70 instruments because a software mismatch may prevent the device from halting when the cover door is opened.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2953-2018·2018-09-05

    Sysmex Fluorocell PLT Reagent Recalled for Inaccurate Platelet Counts

    Sysmex America is recalling Fluorocell PLT reagent because it may cause falsely low platelet and immature platelet fraction results.

    Product
    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 analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0045-2018·2017-11-01

    Sysmex Fluorocell PLT Reagent Recalled for Potential Inaccurate Platelet Results

    Sysmex America is recalling Fluorocell PLT reagent lots because they may produce falsely low platelet results, potentially affecting diagnostic accuracy.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2034-2017·2017-05-10

    Sysmex XN Series Hematology Analyzers Recalled for Fire Risk

    Sysmex America Inc is recalling XN-10 and XN-11 hematology analyzers due to a risk of fire caused by misaligned internal protective sheets.

    Product
    Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2770-2016·2016-09-21

    Sysmex Fluorocell PLT Reagent Recalled for Potential Low Platelet Results

    Sysmex America Inc is recalling Fluorocell PLT reagent because it may produce falsely low platelet results on Sysmex XN-Series analyzers.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0949-2014·2014-02-19

    Sysmex UF-1000i Urine Analyzer Recalled for Software Date Calculation Error

    Sysmex America is recalling 214 UF-1000i urine analyzers because a software patch error prevented proper database file purging, causing system performance issues.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0100-2014·2013-11-06

    Sysmex pocH-100i Automated Hematology Analyzer Recalled for Data Omission

    Sysmex America Inc is recalling 193 pocH-100i Automated Hematology Analyzers because the thermal printer may omit digits or decimal points in printed results.

    Product
    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 Hematol
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0254-2013·2012-11-14

    Sysmex XE-2100 Hematology System Recalled for Reticulocyte Count Bias

    Sysmex America is recalling 1,099 XE-2100 Automated Hematology Systems because reticulocyte counts may be 21% lower than expected due to a low bias.

    Product
    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 dia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0256-2013·2012-11-14

    Sysmex XE-2100C Hematology System Recalled for Reticulocyte Count Bias

    Sysmex America is recalling 69 XE-2100C automated hematology systems because reticulocyte counts may be 21% lower than expected.

    Product
    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 dia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0255-2013·2012-11-14

    Sysmex XE-5000 Hematology System Recalled for Reticulocyte Count Bias

    Sysmex America is recalling 763 XE-5000 automated hematology systems because reticulocyte counts may be 21% lower than expected due to a low bias.

    Product
    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 diagn
    Category
    Medical Device
    Distribution
    Distributed nationwide