{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 6 } }, "results": [ { "cfres_id": "198103", "product_res_number": "Z-1149-2023", "event_date_initiated": "2023-01-09", "event_date_posted": "2023-02-21", "recall_status": "Open, Classified", "res_event_number": "91522", "product_code": "CGN", "k_numbers": [ "K172201" ], "product_description": "Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells.\nSiemens Material Number (SMN): 10995572", "code_info": "(01)00630414598963(10)15308337(17)20230320\t\t\t\t\t\t\n(01)00630414598963(10)27949339(17)20230529\t\t\t\t\t\t\n(01)00630414598963(10)41143343(17)20230630\t\t\t\t\t\n(01)00630414598963(10)41144343(17)20230630\n(01)00630414598963(10)62969345(17)20230726\t\t\t\t\t\t\n\nLot Numbers:\n15308337,\n27949339,\n41143343,\n41144343,\n62969345 and higher.\n\nAffects all current and future lots of the Atellica IM Folate assay until the Instructions for Use are updated.", "firm_fei_number": "1219913", "recalling_firm": "Siemens Healthcare Diagnostics, Inc.", "address_1": "333 Coney St", "city": "East Walpole", "state": "MA", "postal_code": "02032-1516", "additional_info_contact": "SAME\n508-668-5000", "reason_for_recall": "Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.", "root_cause_description": "Under Investigation by firm", "action": "Siemens Healthineers issued Urgent Medical Device Corrections (UMDC AIMC 23-03.A-1.US and AIMC 23-03.A-2.US) to US customers and Urgent Field Safety Notices (UFSN AIMC 23-03.A-1.OUS and AIMC 23-03.A-2.OUS) to customers outside the United States. The UMDCs and UFSNs advise customers to use the appropriate FolSerum calibration instructions when testing serum samples with Atellica IM Folate kit lots\nending in 337 and above or ADVIA Centaur Folate kit lots ending in 336 and above.\n\nLetter states reason for recall, health risk and action to take:\nFollow the instructions in this Urgent Medical Device Correction until the Atellica IM Folate/ADVIA Centaur Folate Instructions for Use are updated.\no Before updating to the new reagent lot, ensure you have processed all serum samples necessary for lot-to-lot comparisons using your existing inventory.\no Once you have updated to the new reagent lot, you will not be able to process serum samples with the previous reagent lot.\no If your laboratory runs both serum and whole blood sample types, then both assays must be calibrated with the new reagent lot.\no If your laboratory runs one sample type, only calibrate the sample type you use\n\nIf you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.", "product_quantity": "13,843 kits", "distribution_pattern": "Nationwide\nForeign:\nAlbania¿¿¿¿¿¿¿¿\nAustria¿¿¿¿¿¿¿¿\nBahrain¿¿¿¿¿¿¿¿\nBelgium¿¿¿¿¿¿¿¿\nBosnia¿Herzeg.¿\nBulgaria¿¿¿¿¿¿¿\nCroatia¿¿¿¿¿¿¿¿\nCura¿ao,¿St¿Eus\nCyprus¿¿¿¿¿¿¿¿¿\nCzech¿Republic¿\nDenmark¿¿¿¿¿¿¿¿\nEstonia¿¿¿¿¿¿¿¿\nFinland¿¿¿¿¿¿¿¿\nFrance¿¿¿¿¿¿¿¿¿\nGeorgia¿¿¿¿¿¿¿¿\nGermany¿¿¿¿¿¿¿¿\nGreece¿¿¿¿¿¿¿¿¿\nHungary¿¿¿¿¿¿¿¿\nIran¿¿¿¿¿¿¿¿¿¿¿\nIreland¿¿¿¿¿¿¿¿\nIsrael¿¿¿¿¿¿¿¿¿\nItaly¿¿¿¿¿¿¿¿¿¿\nJordan¿¿¿¿¿¿¿¿¿\nKenya¿¿¿¿¿¿¿¿¿¿\nLatvia¿¿¿¿¿¿¿¿¿\nLithuania¿¿¿¿¿¿\nMalta¿¿¿¿¿¿¿¿¿¿\nMorocco¿¿¿¿¿¿¿¿\nNepal¿¿¿¿¿¿¿¿¿¿\nNetherlands¿¿¿¿\nNorway¿¿¿¿¿¿¿¿¿\nOman¿¿¿¿¿¿¿¿¿¿¿\nPakistan¿¿¿¿¿¿¿\nPoland¿¿¿¿¿¿¿¿¿\nPortugal¿¿¿¿¿¿¿\nQatar¿¿¿¿¿¿¿¿¿¿\nRomania¿¿¿¿¿¿¿¿\nSaudi¿Arabia¿¿¿\nSerbia¿¿¿¿¿¿¿¿¿\nSlovakia¿¿¿¿¿¿¿\nSlovenia¿¿¿¿¿¿¿\nSpain¿¿¿¿¿¿¿¿¿¿\nSweden¿¿¿¿¿¿¿¿¿\nSwitzerland¿¿¿¿\nTunisia¿¿¿¿¿¿¿¿\nTurkey¿¿¿¿¿¿¿¿¿\nU.A.E.¿¿¿¿¿¿¿¿¿\nUganda¿¿¿¿¿¿¿¿¿\nUkraine¿¿¿¿¿¿¿¿\nUnited¿Kingdom¿\nVatikancity¿¿¿¿\n\nCountry \nAR \nAU \nBR \nBS \nCA \nCL \nCN \nCO \nCR \nDO \nEC \nHK \nIL \nIN \nJP \nKR \nMX \nMY \nNZ \nPE \nPH \nPY \nSA \nSG \nTH \nTW \nUY \nVN \nZA", "openfda": { "k_number": [ "K760133", "K832712", "K944212", "K103716", "K092740", "K792167", "K933571", "K921614", "K972232", "K043318", "K001266", "K051292", "K780508", "K950292", "K091332", "K031756", "K771597", "K822728", "K943297", "K984301", "K893684", "K934121", "K172201", "K780557", "K955434", "K993254", "K932887", "K935286", "K954332", "K923286", "K984166", "K943691", "K760262", "K780148", "K810001", "K951155", "K841302", "K791079", "K082340", "K992365", "K812979", "K800914", "K023397", "K943705", "K943149", "K161646", "K192586", "K803060", "K760207", "K922823", "K981931", "K946184", "K010050", "K921689", "K810186", "K801198", "K233060", "K141426", "K223590", "K960800", "K060774", "K964349", "K991582", "K811177" ], "device_name": "Acid, Folic, Radioimmunoassay", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1295", "device_class": "2", "registration_number": [ "3007111389", "3011989923", "9612316", "3000308930", "2032839", "2050012", "3004192065", "9610529", "3002806944", "3005094123", "9680746", "3005333358", "2250051", "3002642396", "2122870", "8020888", "2517506", "3015969360", "3002809144", "3005529799", "1319681", "3005655287", "1219913", "9610126", "1036362", "3012963943", "3033967997", "2020726", "8031673", "3006198300", "2182595", "3006677029", "3009518015", "2432235" ], "fei_number": [ "3007111389", "3011989923", "3002808328", "3000308930", "2050012", "3002806560", "3004192065", "3002806944", "3005094123", "3005333358", "2250051", "3002642396", "2122870", "2517506", "3015969360", "3002809144", "3005529799", "2967", "3005655287", "1219913", "1000136573", "1036362", "1000206808", "3007019572", "3012963943", "3002806559", "3033967997", "2020726", "3006198300", "2182595", "3006677029", "3004185580", "3009518015", "2432235" ] } } ] }