Recall Z-1136-2026— Sysmex America, Inc.
Class II · Ongoing
Class II FDA medical device recall by Sysmex America, Inc., initiated 2025-12-15. FDA's recall record names no specific 510(k) clearance for this event. Product: TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17. Reason: Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift..
- Recalling firm
- Sysmex America, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-12-15
- Firm location
- Lincolnshire, IL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.