Lincolnshire, IL, United States
Sysmex America, Inc. recalls
6 recalls recorded since 2018, most recently on 15 December 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls6
Ongoing (FDA)2
Terminated or completed4
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 15 December 2025
- Reason
- Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift.
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1136-2026
- TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17
Ongoing Class II Medical devices
- Recall started
- 6 January 2025
- Reason
- Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omission of the probe wash step during antibody pipetting on the PS-10 Sample Preparation System.
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1113-2025
- 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.
Terminated Class II Medical devices
- Recall started
- 6 July 2020
- Terminated
- 21 May 2021
- Reason
- Insufficient amount of antibody without an error message or alarm
- Distribution
- US Nationwide distribution including in the states of AL, AZ, MD, WA, FL, IL.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2687-2020
- 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
Terminated Class II Medical devices
- Recall started
- 9 March 2020
- Terminated
- 24 March 2021
- Reason
- Software mismatch-When the software versions between the SP-50 and CF-70 are not matched, and an error condition occurs requiring the operator to open the cover door of the CF-70 to remove slides or slide magazines from the CF-70, the operation of the CF-70 does not halt.
- Distribution
- USA nationwide distribution in the states of AK, AR, AZ, CA, CO, CT, DE, FL, IL, KY, LA, MA, MD, MI, MO, MS, MT, NC, NJ, NM, NY, OH, OK, OR, PA, TN, TZ, UT and WA..
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1703-2020
- 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
Terminated Class II Medical devices
- Recall started
- 21 January 2020
- Terminated
- 30 January 2023
- Reason
- When excessive amounts of urine spills on the rack transport track and reaches the electrical components of the CV-11 conveyor, there is a potential for smoke and/or sparks which may present a combustion hazard.
- Distribution
- USA: FL, VT, IL.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1717-2020
- Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers.
Terminated Class II Medical devices
- Recall started
- 27 July 2018
- Terminated
- 8 July 2019
- Reason
- The fluorescent platelet counts (PLT-F) and immature platelet fraction (IPF) values can be falsely low when using affected lots of Fluorocell PLT.
- Distribution
- Worldwide Distribution: US (Nationwide) including Puerto Rico; and countries of: Argentina, Brazil, Canada, Chile, Costa Rica, Ecuador, Honduras, and Nicaragua.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2953-2018
- 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 plate
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.