Class 2 Device Recall TS10

• Date Initiated by Firm: December 15, 2025
• Date Posted: January 21, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1136-2026
• Recall Event ID: 98213
• Product Classification: Equipment, laboratory, general purpose, labeled or promoted for a specific medical use - Product Code LXG
• Product: TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17
• Code Information: 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
• FEI Number: 3009711478
• Recalling Firm/ Manufacturer: Sysmex America, Inc.; 577 Aptakisic Rd; Lincolnshire IL 60069-4325
• For Additional Information Contact: Technical Assistance Center (TAC); 888-879-7639
• Manufacturer Reason for Recall: Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift.
• FDA Determined 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 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
• Quantity in Commerce: 44 units
• Distribution: US Nationwide.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.