{"recall":{"id":"fda-device-99213","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Biomerieux Inc recalls VITEK 2 AST-N447 TEST KIT Product reference 424620","firm":"Biomerieux Inc","date":"2026-06-04","reported":"2026-07-15","status":"Ongoing","classification":"Class II","products":[{"name":"VITEK 2 AST-N447 TEST KIT Product reference 424620","code":"Lot 0853293604 UDI-DI 03573026634551 Product is not registered in the US. OUS only.","quantity":"45,900 cards","number":"Z-2715-2026","classification":"Class II"}],"reason":"Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"International distribution to the countries of Belgium and the Netherlands.","nationwide":false,"states":[],"units":"45,900 cards","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=99213","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"0be989d2dbfb747d","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=99213","record":[{"status":"Ongoing","city":"Hazelwood","state":"MO","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99213","recalling_firm":"Biomerieux Inc","address_1":"595 Anglum Rd","address_2":"N/A","postal_code":"63042-2320","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"International distribution to the countries of Belgium and the Netherlands.","recall_number":"Z-2715-2026","product_description":"VITEK 2 AST-N447 TEST KIT  Product reference 424620","product_quantity":"45,900 cards","reason_for_recall":"Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.","recall_initiation_date":"20260604","center_classification_date":"20260709","report_date":"20260715","code_info":"Lot 0853293604  UDI-DI 03573026634551  Product is not registered in the US. OUS only."}]}}