{"url_path":"/fda/device/recalls/Z-1980-2026","section_key":"summary","section_title":"DEVICE Recall: Siemens Healthcare Diagnostics, Inc. — Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-03-18","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1980-2026%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":159,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-1980-2026\n\n**Recalling firm:** Siemens Healthcare Diagnostics, Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-03-18\n**Report date:** 2026-05-06\n\n## Product\nDimension Creatinine Flex reagent cartridge. Material Number: 10872079.\n\n## Reason\nSiemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential imprecision in the Dimension CRE2 quality control (QC) and patient sample results using lot numbers GA6307 and BA7005 on the Dimension System. This imprecision may lead to erroneously decreased or increased creatinine patient results\n\n## Affected lots\nMaterial Number: 10872079. Model Number: DF33B. UDI: (01)00630414595009(10)GA6307(17)20261103, (01)00630414595009(10)BA7005(17)20270105. Lot Numbers: GA6307, BA7005.\n\n## Distribution\nWorldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Brazil, Cambodia, Canada, Chile, China, Columbia, Costa Rica, Ecuador, Egypt, Germany, Honduras, India, Indonesia, Korea, Kuwait, Lebanon, Malaysia, Mexico, Nicaragua, Pakistan, Paraguay, Philippines, Qatar, Saudi Arabia, Serbia, Slovenia, South Africa, Sri Lanka, Taiwan, Thailand, U.A.E., Ukraine, Uruguay, Vietnam, Yemen."}