{"recall":{"id":"fda-device-99885","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Life Technologies Holdings Pte Ltd recalls Ion Torrent Genexus Dx with software","firm":"Life Technologies Holdings Pte Ltd","date":"2026-08-14","reported":"2026-10-28","status":"Ongoing","classification":"Class II","products":[{"name":"Ion Torrent Genexus Dx with software, Catalog: A40003539, which supports the Ion Torrent Genexus Dx Integrated Sequencer","code":"UDI-DI: 10190302018883, Software: 6.8.2.1 and earlier. Sequencer UDI-DI: 10190302017794. Sequencer Serial Numbers: 2619124040913, 2619726010247, 2619124060941, 2619124060942, 2619725090229, 2619725100238, 2619122070666, 2619725080220, 2619725090226, 2619726010251, 2619726020265, 2619725090225, 2619725100235, 2619725050205, 2619726010249, 2619122070658","quantity":"16","number":"Z-0211-2027","classification":"Class II"}],"reason":"DNA or RNA sequencing system software has vulnerabilities.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of PA, NC, CO, CA, LA, KY, NY, AZ, MA, LA, OK.","nationwide":true,"states":[],"units":"16","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99885","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"4223b8e627f7b798","firstSeen":"2026-11-02T22:17:07.772Z","updatedAt":"2026-11-02T22:17:07.772Z","history":[]},"official":{"fetchedAt":"2026-11-02T22:17:07.772Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99885","record":[{"status":"Ongoing","city":"Singapore","state":"","country":"Singapore","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99885","recalling_firm":"Life Technologies Holdings Pte Ltd","address_1":"Blk 33 Marsiling Ind Estate Road 3","address_2":"#07-06","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of PA, NC, CO, CA, LA, KY, NY, AZ, MA, LA, OK.","recall_number":"Z-0211-2027","product_description":"Ion Torrent Genexus Dx with software, Catalog: A40003539, which supports the Ion Torrent Genexus Dx Integrated Sequencer","product_quantity":"16","reason_for_recall":"DNA or RNA sequencing system software has vulnerabilities.","recall_initiation_date":"20260814","center_classification_date":"20261022","report_date":"20261028","code_info":"UDI-DI: 10190302018883, Software: 6.8.2.1 and earlier. Sequencer UDI-DI: 10190302017794. Sequencer Serial Numbers:  2619124040913, 2619726010247, 2619124060941, 2619124060942, 2619725090229,  2619725100238, 2619122070666,  2619725080220, 2619725090226, 2619726010251, 2619726020265, 2619725090225, 2619725100235, 2619725050205, 2619726010249, 2619122070658","more_code_info":""}]}}