{"url_path":"/fda/device/recalls/Z-2975-2026","section_key":"summary","section_title":"DEVICE Recall: Siemens Healthcare Diagnostics, Inc. — Syva EMIT 2000 Quinidine Assay  REF: 4Q019UL  Contents: 1x28 mL, 1x14mL","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-2975-2026%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":101,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2975-2026\n\n**Recalling firm:** Siemens Healthcare Diagnostics, Inc.\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\nSyva EMIT 2000 Quinidine Assay  REF: 4Q019UL  Contents: 1x28 mL, 1x14mL\n\n## Reason\nDue to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.\n\n## Affected lots\nLot U1/UDI: 00842768001048\n\n## Distribution\nWorldwide - US Nationwide distribution in the state of CA and the country of Italy."}