{ "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": "177144", "product_res_number": "Z-0829-2020", "event_date_initiated": "2019-07-22", "event_date_posted": "2020-01-21", "recall_status": "Terminated", "event_date_terminated": "2025-02-14", "res_event_number": "84078", "product_code": "CGN", "k_numbers": [ "K010050" ], "product_description": "Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells\nSMN:10310308", "code_info": "All lots", "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": "Homocysteine Assay May Cause Elevated Results in the Folate Assay", "root_cause_description": "Device Design", "action": "Siemens issued Urgent Medical Device Correction, CC 19-07.A.US to customers on July 22, 2019 to be delivered to customers on July 23, 2019. After release of the letter (CC 19-07.A.US), we identified a typographical error in Table 1, specifically the Reference kit SMN (19331250). Version B (CC 19-07-B.US) is being created with the corrected SMN Number (10331250) and distributed to the reference accounts that order SMN (Quest Diagnostics). Urgent Field Safety Notice, CC 19-07.A.OUS was sent out to the\ncountry organizations on July 19, 2019 for distribution to customers outside the United States. The customer distribution included all customers that have received both ADVIA Centaur Folate and ADVIA Centaur Homocysteine over the past year.\n\nThe letters inform customers the potential for the ADVIA Centaur Homocysteine assay to cause elevated Folate results when an ADVIA Centaur Folate test immediately follows an ADVIA Centaur Homocysteine test. The communications provide recommendations to run the assays on different ADVIA Centaur systems or on other Siemens Healthcare systems or to test all Homocysteine samples together followed by the Daily Cleaning Procedure prior to testing the Folate assay to mitigate the interference.\n\nField Correction Effectiveness Check form provided.\nQuestions contact your Siemens Customer Care Center or your local Siemens technical support representative.\n\nUpdate: 11/30/20\nSiemens issued Follow Up Customer Notification CC 19-07.C.US and or CC 19-07.B.OUS, dated Dec.1, 2020 via overnight to US customers on December 1st, 2020 and Siemens EU Authorized Representatives issued the letter to OUS countries on December 1st, 2020, stating:Siemens has implemented a new wash mitigation into ADVIA Centaur XPT Folate (FOL) Test Definition (TDef) Version 2.1 and ADVIA Centaur XPT Homocysteine (HCY) TDef Version 1.5 for use on the ADVIA Centaur XPT system and TDef Version EL/EM on the ADVIA Centaur XP system.\nActions to be Taken by the Custome", "product_quantity": "12,796 kits", "distribution_pattern": "Nationwide\nForeign:\nArmenia¿¿¿¿¿¿¿¿\nAustria¿¿¿¿¿¿¿¿\nBahrain¿¿¿¿¿¿¿¿\nBelgium¿¿¿¿¿¿¿¿\nBosnia¿Herzeg.¿\nCzech¿Republic¿\nDenmark¿¿¿¿¿¿¿¿\nEgypt¿¿¿¿¿¿¿¿¿¿\nFrance¿¿¿¿¿¿¿¿¿\nGeorgia¿¿¿¿¿¿¿¿\nGermany¿¿¿¿¿¿¿¿\nGreece¿¿¿¿¿¿¿¿¿\nHungary¿¿¿¿¿¿¿¿\nIran¿¿¿¿¿¿¿¿¿¿¿\nIreland¿¿¿¿¿¿¿¿\nIsrael¿¿¿¿¿¿¿¿¿\nItaly¿¿¿¿¿¿¿¿¿¿\nJordan¿¿¿¿¿¿¿¿¿\nLithuania¿¿¿¿¿¿\nNepal¿¿¿¿¿¿¿¿¿¿\nNetherlands¿¿¿¿\nNorway¿¿¿¿¿¿¿¿¿\nPakistan¿¿¿¿¿¿¿\nPoland¿¿¿¿¿¿¿¿¿\nPortugal¿¿¿¿¿¿¿\nQatar¿¿¿¿¿¿¿¿¿¿\nRomania¿¿¿¿¿¿¿¿\nRussian¿Fed.¿¿¿\nSerbia¿¿¿¿¿¿¿¿¿\nSlovakia¿¿¿¿¿¿¿\nSlovenia¿¿¿¿¿¿¿\nSpain¿¿¿¿¿¿¿¿¿¿\nSudan¿¿¿¿¿¿¿¿¿¿\nSweden¿¿¿¿¿¿¿¿¿\nSwitzerland¿¿¿¿\nTurkey¿¿¿¿¿¿¿¿¿\nU.A.E.¿¿¿¿¿¿¿¿¿\nUnited¿Kingdom¿\nVatikancity¿¿¿¿", "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" ] } } ] }