{"url_path":"/fda/device/recalls/Z-2067-2026","section_key":"summary","section_title":"DEVICE Recall: BioFire Diagnostics, LLC — BioFire Joint Infection (JI) Panel  REF: RFIT-ASY-0138, 30 test Kit.","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-04-22","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2067-2026%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":96,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2067-2026\n\n**Recalling firm:** BioFire Diagnostics, LLC\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-22\n**Report date:** 2026-05-13\n\n## Product\nBioFire Joint Infection (JI) Panel  REF: RFIT-ASY-0138, 30 test Kit.\n\n## Reason\nContamination to in-vitro diagnostic test   may result in false positives.\n\n## Affected lots\nLot #s:0883425,0878825/DI: 00815381020192\n\n## Distribution\nWorldwide - US Nationwide distribution in the states of TX, NC, UT, MD and the countries of France, Italy, Germany, Spain, Belgium, Switzerland, United Kingdom, Netherlands, Poland, Austria, India, Finland, Czech Republic, Egypt, Lebanon, Morocco, Slovenia, Romania, \tDominican Republic, Serbia."}