Recall Z-1136-2026 ยท LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Sysmex America, Inc.
TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17
| Date | Jan 21, 2026 (initiated Dec 15, 2025) |
| Status | Open, Classified |
| Reason | Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift. |
| Root cause | Software design |
| Action | A Product Notification Field Action was sent to customers on 12/15/25. Actions for customers 1. To prevent injury, never place your hands around the lift section at any time. 2. In addition, please follow these instructions when handling rack jams or similar errors: " Pay special attention not to insert your hands around the lift section during any intervention. " If a rack, tube, or any object becomes lodged around the lift section, turn off the power. After confirming that the lift section has moved to the bottom dead point, carefully remove the rack and blood collection tubes. " If the rac |
| Quantity | 44 units |
| Distribution | US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.