{"recall":{"id":"fda-device-98927","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Beckman Coulter Biomedical GmbH recalls REMISOL Advance with Software Version 2","firm":"Beckman Coulter Biomedical GmbH","date":"2026-04-29","reported":"2026-08-12","status":"Ongoing","classification":"Class II","products":[{"name":"REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 connections","code":"Software Version 2.5 UDI-DI code: 15099590802073","quantity":"20 systems","number":"Z-2834-2026","classification":"Class II"}],"reason":"Due to software issues where does not handle combo assay results. The software may replace the final combo test result with one of the sub-results resulting in incorrect reporting of test outcomes.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"U.S.: FL, GA, IL, MI, and PA  O.U.S.: Belgium, France, Hungary, Poland, Taiwan (Province of China), Tunisia, United Arab Emirates, and United Kingdom of Great Britain and Northern Ireland.","nationwide":false,"states":["FL","GA","IL","MI","PA"],"units":"20 systems","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=98927","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"a7eaaae7580eacf3","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","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=98927","record":[{"status":"Ongoing","city":"Munchen","state":"","country":"Germany","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"98927","recalling_firm":"Beckman Coulter Biomedical GmbH","address_1":"Sauerbruchstr. 50","address_2":"","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"U.S.: FL, GA, IL, MI, and PA  O.U.S.: Belgium, France, Hungary, Poland, Taiwan (Province of China), Tunisia, United Arab Emirates, and United Kingdom of Great Britain and Northern Ireland.","recall_number":"Z-2834-2026","product_description":"REMISOL Advance with Software Version 2.5  UDI-DI code: 15099590802073    The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 connections","product_quantity":"20 systems","reason_for_recall":"Due to software issues where does not handle combo assay results.  The software may replace the final combo test result with one of the sub-results resulting in incorrect reporting of test outcomes.","recall_initiation_date":"20260429","center_classification_date":"20260731","report_date":"20260812","code_info":"Software Version 2.5 UDI-DI code: 15099590802073","more_code_info":""}]}}