TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running s

FDA device recall Z-1136-2026 · posted 2026-01-21 · Open, Classified

Recall details

Recalling firm

Sysmex America, Inc.

Reason for recall

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

Action taken

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 rack or blood collection tubes are jammed in the lift section and cannot be removed with one hand, contact Sysmex for assistance. 3. Sysmex will implement a software update to improve lift position control to prevent unintended sudden drops of the lift section by ensuring that, after an error occurs, the lift automatically returns to the home position. Our service team will contact you to schedule the installation of software version 00-18 by 12/31/2025. 4. Software update acknowledgement a. To assist Sysmex with the field safety communication, please acknowledge the communication by proceeding to the URL below to complete and submit the Acknowledgement Form. See Figure 1. URL: https://pages.sysmex.com/TS-10-Acknowledgement.html b. On the Acknowledgement Form at the URL, you will be directed to enter First/Last Name, Role/Title, Email Address, Phone #, Facility Name, Street Address, City, State / Province, Zip Code, Device Serial Number and acknowledge receipt of the notice by selecting Yes. c. Once the Acknowledgement Form is completed, a confirmation email will be sent to your email address. NOTE: If you do not see the email confirmation, check the SPAM or JUNK folders of your email box. 5. Please distribute this Product Notification as appropriate to your laboratory staff. 6. File this Product Notification as a part of your laboratory s Quality System as required. Questions

Root cause

Software design

Status

Open, Classified

Product code

LXG

Quantity affected

44 units

Distribution

US Nationwide.

Date initiated

2025-12-15

Date posted

2026-01-21

Location

Lincolnshire, IL