Sysmex America, Inc.: Device Recall

Recall #Z-1136-2026 · 12/15/2025

Class II: Risk

Recall Details

Recall Number: Z-1136-2026
Classification: Class II
Product Type: Device
Recalling Firm: Sysmex America, Inc.
Status: Ongoing
Date Initiated: 12/15/2025
Location: Lincolnshire, IL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 44 units

Reason for Recall

Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift.

Product Description

TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17

Distribution Pattern

US Nationwide.

Other Recalls by Sysmex America, Inc.

Class II: Risk 01/06/2025

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.

View all recalls by Sysmex America, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.