{"recall":{"id":"fda-device-99450","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Remel Europe Ltd. recalls Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL","firm":"Remel Europe Ltd.","date":"2026-07-17","reported":"2026-08-19","status":"Ongoing","classification":"Class II","products":[{"name":"Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics","code":"UDI/DI 05056080501161, Lot Numbers: 6214791, exp. 18/03/2025; 6175327, exp. 04/12/2027; 6148809, exp. 30/09/2027; 6002010, exp. 31/07/2027.","quantity":"26 units","number":"Z-2927-2026","classification":"Class II"}],"reason":"Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution.","nationwide":true,"states":[],"units":"26 units","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=99450","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"f3078d91c4bcd99f","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=99450","record":[{"status":"Ongoing","city":"Dartford","state":"","country":"United Kingdom","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99450","recalling_firm":"Remel Europe Ltd.","address_1":"Clipper Boulevard West","address_2":"Ken","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution.","recall_number":"Z-2927-2026","product_description":"Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics","product_quantity":"26 units","reason_for_recall":"Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.","recall_initiation_date":"20260717","center_classification_date":"20260807","report_date":"20260819","code_info":"UDI/DI 05056080501161, Lot Numbers:  6214791, exp. 18/03/2025; 6175327, exp. 04/12/2027; 6148809, exp. 30/09/2027; 6002010, exp. 31/07/2027.","more_code_info":""}]}}