{"url_path":"/fda/device/recalls/Z-2171-2026","section_key":"summary","section_title":"DEVICE Recall: Aniara Diagnostica LLC — ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A","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-2171-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Aniara Diagnostica LLC"},"word_count":96,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2171-2026\n\n**Recalling firm:** Aniara Diagnostica LLC\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-01\n**Report date:** 2026-05-20\n\n## Product\nZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A\n\n## Reason\nKits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.\n\n## Affected lots\nUDI-DI: 03663537018763; Lot Number: FD1265\n\n## Distribution\nUS Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI"}