TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Num...

FDA Recall #Z-1136-2026 — Class II — December 15, 2025

Recall #Z-1136-2026 Date: December 15, 2025 Classification: Class II Status: Ongoing

Product Description

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

Reason for Recall

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

Recalling Firm

Sysmex America, Inc. — Lincolnshire, IL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

44 units

Distribution

US Nationwide.

Code Information

Serial Numbers: 11281 11611 11918 11790 12040 11991 12218 11950 11795 11533 11635 12054 11610 11453 11753 11539 11990 12298 11774 11541 11981 11788 11834 12005 11907 11524 12237 11246 12154 12104 12299 12176 11711 11420 12153 12177 12074 11405 11303 12039 11250 11336 12137 12075

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated