Sysmex America, Inc. recalls TS-10/TS-10H Tube Sorter

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

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

• FDA enforcement recordOfficial FDA database entry for Z-1136-2026
• FDA device classification · LXGOfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.2050The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Sysmex America, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.