{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "217906", "product_res_number": "Z-1136-2026", "event_date_initiated": "2025-12-15", "event_date_posted": "2026-01-21", "recall_status": "Open, Classified", "res_event_number": "98213", "product_code": "LXG", "product_description": "TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17", "code_info": "Serial Numbers: 11281\n11611\n11918\n11790\n12040\n11991\n12218\n11950\n11795\n11533\n11635\n12054\n11610\n11453\n11753\n11539\n11990\n12298\n11774\n11541\n11981\n11788\n11834\n12005\n11907\n11524\n12237\n11246\n12154\n12104\n12299\n12176\n11711\n11420\n12153\n12177\n12074\n11405\n11303\n12039\n11250\n11336\n12137\n12075", "firm_fei_number": "3009711478", "recalling_firm": "Sysmex America, Inc.", "address_1": "577 Aptakisic Rd", "city": "Lincolnshire", "state": "IL", "postal_code": "60069-4325", "additional_info_contact": "Technical Assistance Center (TAC)\n888-879-7639", "reason_for_recall": "Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift.", "root_cause_description": "Software design", "action": "A Product Notification Field Action was sent to customers on 12/15/25.\n\nActions for customers\n1. To prevent injury, never place your hands around the lift section at any time.\n2. In addition, please follow these instructions when handling rack jams or similar errors:\n\" Pay special attention not to insert your hands around the lift section during any\nintervention.\n\" If a rack, tube, or any object becomes lodged around the lift section, turn off the power.\nAfter confirming that the lift section has moved to the bottom dead point, carefully remove the rack and blood collection tubes.\n\" If the rack or blood collection tubes are jammed in the lift section and cannot be removed with one hand, contact Sysmex for assistance.\n3. 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.\n4. Software update acknowledgement\na. To assist Sysmex with the field safety communication, please acknowledge the\ncommunication by proceeding to the URL below to complete and submit the\nAcknowledgement Form. See Figure 1.\nURL: https://pages.sysmex.com/TS-10-Acknowledgement.html\nb. 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. \nc. Once the Acknowledgement Form is completed, a confirmation email will be sent to your email address.\nNOTE: If you do not see the email confirmation, check the SPAM or JUNK folders of your\nemail box.\n5. Please distribute this Product Notification as appropriate to your laboratory staff.\n6. File this Product Notification as a part of your laboratory s Quality System as required.\n\nQuestions", "product_quantity": "44 units", "distribution_pattern": "US Nationwide.", "openfda": { "k_number": [ "K943466", "K896802", "K021927" ], "registration_number": [ "3042244574", "3019837962", "1531062", "3023162659", "3008514604", "3012462466", "3012727921", "3009732568", "3008349578", "1319681", "3030178466", "3002759288", "3003423869", "1220502", "3000148879", "3005592623", "3003895930", "9610942", "9680794", "3017450368", "3021013122", "3002889627", "2182202", "2013736", "3030516433", "3009155756", "3021247124", "3009963993", "2032600", "3022177334", "3043127699", "3004973569", "3009288740", "3017178434", "3004784537", "3010288357", "3044466317", "1424489", "3006210673", "3008249922", "3013024191", "3004111573", "1000391282", "3008937875", "1419341", "3003542872", "3003587189", "9617465", "3005739529", "1317188", "1417592", "3020703807", "1832216", "3008776165", "3015505238", 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