{"recall":{"id":"fda-device-99749","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-N461 TEST KIT","firm":"Biomerieux Inc","date":"2026-07-24","reported":"2026-09-30","status":"Ongoing","classification":"Class II","products":[{"name":"VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811","code":"UDI-DI 03573026637712; Lot Number 1333393504","quantity":"97680 units","number":"Z-3231-2026","classification":"Class II"}],"reason":"The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific timeframe, causing a potential risk of false resistant results. False resistant results may lead to the use of less effective antibiotic treatments or the association of multiple antibiotics having negative side effects, which could potentially impact patient s health.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"International distribution to the countries of Austria, Germany, Luxembourg.","nationwide":false,"states":[],"units":"97680 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=99749","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"e84036c545b24718","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=99749","record":[{"status":"Ongoing","city":"Hazelwood","state":"MO","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99749","recalling_firm":"Biomerieux Inc","address_1":"595 Anglum Rd","address_2":"","postal_code":"63042-2320","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"International distribution to the countries of Austria, Germany, Luxembourg.","recall_number":"Z-3231-2026","product_description":"VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811","product_quantity":"97680 units","reason_for_recall":"The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific timeframe, causing a potential risk of false resistant results. False resistant results may lead to the use of less effective antibiotic treatments or the association of multiple antibiotics having negative side effects, which could potentially impact patient s health.","recall_initiation_date":"20260724","center_classification_date":"20260918","report_date":"20260930","code_info":"UDI-DI 03573026637712; Lot Number 1333393504","more_code_info":""}]}}