{"recall":{"id":"fda-device-99261","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"BioFire Diagnostics, LLC recalls BIOFIRE Respiratory Panel 2","firm":"BioFire Diagnostics, LLC","date":"2026-06-24","reported":"2026-08-19","status":"Ongoing","classification":"Class II","products":[{"name":"BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic","code":"Part Number: 423742 UDI-DI code: 00815381020529 Pouch Lot: 3VLB25 Kit Lot: 1872125","quantity":"2,370 pouches (79 kits)","number":"Z-2936-2026","classification":"Class II"}],"reason":"Due to increase in false negative results","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"U.S. Nationwide distribution in the states of AL, AR, IA, IL, KS, LA, MN, MO, TX, and WI.","nationwide":true,"states":[],"units":"2,370 pouches (79 kits)","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=99261","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"5872158fb0d90fab","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=99261","record":[{"status":"Ongoing","city":"Salt Lake City","state":"UT","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99261","recalling_firm":"BioFire Diagnostics, LLC","address_1":"515 S Colorow Dr","address_2":"","postal_code":"84108-1248","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"","distribution_pattern":"U.S. Nationwide distribution in the states of AL, AR, IA, IL, KS, LA, MN, MO, TX, and WI.","recall_number":"Z-2936-2026","product_description":"BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742  UDI code: 00815381020529    PCR-based multiplexed nucleic acid test, in vitro diagnostic","product_quantity":"2,370 pouches (79 kits)","reason_for_recall":"Due to increase in false negative results","recall_initiation_date":"20260624","center_classification_date":"20260812","report_date":"20260819","code_info":"Part Number: 423742 UDI-DI code: 00815381020529 Pouch Lot: 3VLB25 Kit Lot: 1872125","more_code_info":""}]}}