{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "123046", "product_res_number": "Z-0569-2014", "event_date_initiated": "2013-11-06", "event_date_posted": "2013-12-24", "recall_status": "Terminated", "event_date_terminated": "2017-03-23", "res_event_number": "66713", "product_code": "CGN", "k_numbers": [ "K943705" ], "product_description": "IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 tests), Siemens Material Number (SMN) 10380902, IVD; for in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers --- Siemens Healthcare Diagnostics Products Ltd. \r\nAn IVD for the quantitative measurement of folic acid in serum, heparinized plasma or ascorbic acid-treated whole blood, as an aid in clinical diagnosis and treatment of anemia.", "code_info": "Kit Lots 335, 336, and 337", "firm_fei_number": "2432235", "recalling_firm": "Siemens Healthcare Diagnostics", "address_1": "511 Benedict Ave", "city": "Tarrytown", "state": "NY", "postal_code": "10591-5005", "reason_for_recall": "potential for an accelerated decline in counts per second (CPS) for three IMMULITE/IMMULITE 1000 Folic Acid kit lots. This may lead to a failed adjustment before the labeled expiration date is reached.", "root_cause_description": "Unknown/Undetermined by firm", "action": "Siemens sent an Urgent Medical Device Correction notices dated November 7 2013, via FedEx to the US customers. The letter identified the product the problem and the action needed to be taken by the customers.\r\n\r\nCustomers are instructed that If the adjustment slope is less than or equal to 1.8 and quality control results are within the established ranges, the kit may be used to generate patient results. If the adjustment slope is greater than 1.8, customers are instructed to discontinue use and discard the kit lots. Ex-US distribution is determined at the country level. Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter within thirty (30) days. Field service personnel were sent a support document describing the issue and instructing them how to deal with customer questions.\r\n\r\nFor further questions please call CUSTOMER CARE CENTER NUMBER: (302) 631-7597.", "product_quantity": "Domestic: 442 kits; Foreign: 680 kits", "distribution_pattern": "Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of Argentina, Bosnia-Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Denmark, Dominican Republic, Estonia, France, Germany, Great Britain, Greece, Guatemala, Hungary, India, Italy, Latvia, Mexico, Netherlands, Panama, Paraguay, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Tunisia, United Arab Emirates, Uzbekistan and Venezuela.", "openfda": { "k_number": [ "K960800", "K811177", "K954332", "K810001", "K043318", "K082340", "K060774", "K950292", "K760133", "K803060", "K984301", "K921689", "K972232", "K780148", "K943149", "K935286", "K964349", "K810186", "K923286", "K800914", "K001266", "K946184", "K893684", "K921614", "K223590", "K841302", "K955434", "K932887", "K951155", "K780557", "K760262", "K010050", "K933571", "K780508", "K943705", "K092740", "K091332", "K801198", "K992365", "K822728", "K023397", "K832712", "K771597", "K192586", "K981931", "K161646", "K791079", "K943691", "K922823", "K760207", "K993254", "K031756", "K103716", "K233060", "K792167", "K984166", "K991582", "K934121", "K943297", "K812979", "K172201", "K944212", "K051292", "K141426" ], "device_name": "Acid, Folic, Radioimmunoassay", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1295", "device_class": "2", "registration_number": [ "3015969360", "2432235", "9612316", "8031673", "2182595", "2020726", "2050012", "3005529799", "3002642396", "3002809144", "3007111389", "3006198300", "3009518015", "1219913", "3011989923", "1036362", "9610126", "2122870", "3005655287", "2250051", "3002806944", "9680746", "3006677029", "3004192065", "2517506", "8020888", "3000308930", "3005094123", "1319681", "3005333358", "2032839", "3012963943", "9610529", "3033967997" ], "fei_number": [ "3002808328", "3015969360", "2432235", "2182595", "3002806559", "2020726", "1000206808", "2050012", "3005529799", "3002642396", "3002809144", "3007111389", "3006198300", "3009518015", "1219913", "3011989923", "1036362", "3004185580", "2122870", "3002806560", "3005655287", "2250051", "3002806944", "1000136573", "3006677029", "3004192065", "2517506", "3000308930", "3005094123", "2967", "3005333358", "3012963943", "3007019572", "3033967997" ] } } ] }