{"url_path":"/fda/device/recalls/Z-2083-2026","section_key":"summary","section_title":"DEVICE Recall: DFI Co., Ltd. — One Step UTI in vitro diagnostic test    REF: 3374","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-04-02","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2083-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"DFI Co., Ltd."},"word_count":75,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2083-2026\n\n**Recalling firm:** DFI Co., Ltd.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-02\n**Report date:** 2026-05-13\n\n## Product\nOne Step UTI in vitro diagnostic test    REF: 3374\n\n## Reason\nThe devices were distributed without required FDA premarket clearance or approval.\n\n## Affected lots\nUDI: 08806141303480/ Lot: 241023, 250625, 250905\n\n## Distribution\nWorldwide - US Nationwide distribution in the states of FL, PA and the country of England."}