{"url_path":"/fda/device/recalls/Z-2398-2026","section_key":"summary","section_title":"DEVICE Recall: Siemens Healthcare Diagnostics, Inc. — Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-05-07","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2398-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Siemens Healthcare Diagnostics, Inc."},"word_count":113,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2398-2026\n\n**Recalling firm:** Siemens Healthcare Diagnostics, Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-07\n**Report date:** 2026-06-17\n\n## Product\nSiemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay\n\n## Reason\nA potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.\n\n## Affected lots\nManufacturing Lot/Serial Numbers:  FA6254, FA6260, FA6286;  UDIs:  (01)00842768035425(10)FA6254(17)20260911;  (01)00842768035425(10)FA6260(17)20260917;  (01)00842768035425(10)FA6286(17)20261013.\n\n## Distribution\nWorldwide distribution - US Nationwide and the countries of Argentina, Austria, Brazil, Croatia, Germany, Hungary, India, Italy, Japan, Korea, Lithuania, Pakistan, Poland, Saudi Arabia, Spain, South Africa, Sri Lanka, Turkey, United Arab Emirates."}