{"url_path":"/fda/device/recalls/Z-2965-2026","section_key":"summary","section_title":"DEVICE Recall: Siemens Healthcare Diagnostics Products Ltd. — Siemens Healthineers  Immulite 2000 Systems SYP Syphilis Screen  REF:L2KSY2(D)/10471981  IVD, RxOnly","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-07-13","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2965-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Siemens Healthcare Diagnostics Products Ltd."},"word_count":112,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2965-2026\n\n**Recalling firm:** Siemens Healthcare Diagnostics Products Ltd.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-07-13\n**Report date:** 2026-08-26\n\n## Product\nSiemens Healthineers  Immulite 2000 Systems SYP Syphilis Screen  REF:L2KSY2(D)/10471981  IVD, RxOnly\n\n## Reason\nSyphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.\n\n## Affected lots\nLot Code: D387/UDI: 00630414976891\n\n## Distribution\nWorldwide - US Nationwide distribution in the states of FL, NJ, NY  and the countries of Austria, Azerbaijan, Belgium, Brazil, Chile, Colombia, Cura-ao, St.¿Eus Cyprus, France, Germany, Italy, Kazakhstan, Latvia, Lithuania, Netherlands, Romania, Russian¿Fed., Saudi¿Arabia, Slovakia, Slovenia, South¿Africa, Spain, U.A.E., Ukraine, United¿Kingdom, Uzbekistan.¿¿¿¿¿"}