{"url_path":"/fda/device/recalls/Z-2081-2026","section_key":"summary","section_title":"DEVICE Recall: BioFire Diagnostics, LLC — Biofire Spotfire Respiratory/Sore Throat Panel  REF: 423485","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-04-01","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2081-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"BioFire Diagnostics, LLC"},"word_count":68,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2081-2026\n\n**Recalling firm:** BioFire Diagnostics, LLC\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-01\n**Report date:** 2026-05-13\n\n## Product\nBiofire Spotfire Respiratory/Sore Throat Panel  REF: 423485\n\n## Reason\nRespiratory/sore throat panel  test may result in false negative results and control failures.\n\n## Affected lots\nLot Number: 2215125/UDI: 00815381020390\n\n## Distribution\nUS Nationwide distribution in the states of MS, TX MN, VA."}