{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "219398", "product_res_number": "Z-1980-2026", "event_date_initiated": "2026-03-18", "event_date_posted": "2026-04-28", "recall_status": "Open, Classified", "res_event_number": "98666", "product_code": "CGX", "k_numbers": [ "K132638" ], "product_description": "Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.", "code_info": "Material Number: 10872079. Model Number: DF33B. UDI: (01)00630414595009(10)GA6307(17)20261103, (01)00630414595009(10)BA7005(17)20270105. Lot Numbers: GA6307, BA7005.", "firm_fei_number": "2517506", "recalling_firm": "Siemens Healthcare Diagnostics, Inc.", "address_1": "500 Gbc Dr", "city": "Newark", "state": "DE", "postal_code": "19702-2466", "additional_info_contact": "800-441-9250", "reason_for_recall": "Siemens 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", "root_cause_description": "Under Investigation by firm", "action": "Siemens Healthineers notified consignees on about 03/18/2026 via letter. Consignees were notified of the issue, the hazard involved and instructed to immediately discontinue use of and discard the affected kit lots, each facility should review the recall notification with their Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable, and review inventory to determine the laboratory's replacement needs and communicate that with Siemens Healthineers. Consignees were also instructed to complete and return the Field Correction Effectiveness Check Form provided and retain the letter with laboratory records and forward it to anyone how may have received or used the affected product.", "product_quantity": "18,080 units", "distribution_pattern": "Worldwide 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.", "openfda": { "k_number": [ "K905619", "K901298", "K772157", "K800685", "K880843", "K970087", "K821199", "K890671", "K851849", "K771834", "K083809", "K842159", "K781396", "K915077", "K072115", "K823573", "K791688", "K000055", "K792402", "K023407", "K820075", "K813560", "K792397", "K781884", "K945655", "K896686", "K931939", "K923039", "K863079", "K061193", "K895022", "K770454", "K852565", "K001769", "K971908", "K941837", "K071283", "K800583", "K780514", "K133728", "K830537", "K791689", "K040976", "K924692", "K950142", "K831627", "K983937", "K771443", "K771916", "K050652", "K821881", "K991109", "K955938", "K861819", "K902172", "K060935", "K772107", "K832439", "K900666", "K830447", "K934361", "K934071", "K913707", "K923203", "K863261", "K873131", "K951595", "K790044", "K923526", "K771773", "K251058", "K943005", "K903296", "K813043", "K761280", "K242685", "K844024", "K823806", "K870366", "K901229", "K873531", "K973993", "K033058", "K812109", "K770643", "K843179", "K861655", "K800219", "K161494", "K792404", "K802156", "K823572", "K132638", "K782094", "K071280", "K924599", "K881856", "K843916", "K863738", "K925668", "K963534", "K932160", "K770819", "K071277", "K881400", "K926511", "K880629", "K210452", "K003247", "K252206", "K851993", "K853888", "K954266", "K884734", "K873310", "K822118", "K221813", "K850932", "K830556", "K771856", "K933697", "K905658", "K873725", "K110530", "K972743", "K771335", "K873365", "K981240", "K893582", "K943924", "K002156", "K771365", "K770242", "K811664", "K872310", "K811659", "K812834", "K843377", "K840872", "K803087", "K844332", "K123586", "K811406", "K860418", "K974909", "K841377", "K895847", "K981799", "K831628", "K855193", "K874088", "K843105", "K934587", "K761279", "K902561", "K791994", "K854846", "K910147", "K854178" ], "device_name": "Alkaline Picrate, Colorimetry, Creatinine", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1225", "device_class": "2", "registration_number": [ "1827821", "2050010", "1818910", "9610633", "3005333358", "2030861", "1220972", "3021841051", "1616487", "2939693", "3010825766", "8020316", "1832216", "3004875840", "3002637618", "1181121", "2050012", "3011989923", "3016438761", "3006716639", "2247288", "2517506", "9616671", "3005094123", "2432235", "3003795116", "3002809144", "3000148879", "9610529", "1219029", "1063851", "3006198300", "3003030793", "3004192065", "9680746", "2085064", "3004493545", "3023162659", "3003593973", "9610126", "3005146313" ], "fei_number": [ "1827821", "2050010", "1818910", "3002806809", "3005333358", "3002806693", "1220972", "3002806559", "3021841051", "1000206808", "1000135102", "1616487", "2939693", "3010825766", "1832216", "3004875840", "3002637618", "1181121", "2050012", "3011989923", "3016438761", "3006716639", "1000122044", "2517506", "3005094123", "2432235", "3003795116", "3002809144", "3000215862", "3000148879", "1219029", "3006198300", "1000442352", "3003030793", "3004192065", "3002806560", "3004493545", "3023162659", "3003593973", "3002854251", "3005146313" ] } } ] }