FDA Enforcement
Class II
Ongoing
TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17
Recall: Z-1136-2026
·
Reported January 28, 2026
Enforcement
- Recall Number
- Z-1136-2026
- Event ID
- 98213
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Sysmex America, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 28, 2026
- Initiation Date
- December 15, 2025
- Classification Date
- January 21, 2026
- Address
- 577 Aptakisic Rd, Lincolnshire, IL, 60069-4325, United States
Description
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.
Code Info
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
Distribution
US Nationwide.
Quantity
44 units