{ "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": "115333", "product_res_number": "Z-0745-2013", "event_date_initiated": "2012-12-20", "event_date_posted": "2013-01-29", "recall_status": "Terminated", "event_date_terminated": "2014-01-08", "res_event_number": "64081", "product_code": "JIS", "k_numbers": [ "K060266" ], "product_description": "Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010.\n\nThe Dimension(R) IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the Iron method for the Dimension(R) clinical chemistry system.", "code_info": "Siemens material number 10445010 -- and lot numbers 2DN060, exp 2013-10-01; 2FN063, exp 2013-12-01; 2GN068, exp 2014-01-01; and 2JN073, exp 2014-03-01.", "firm_fei_number": "2517506", "recalling_firm": "Siemens Healthcare Diagnostics, Inc.", "address_1": "500 Gbc Dr Ms 514", "address_2": "PO BOX 6101", "city": "Newark", "state": "DE", "postal_code": "19702-2466", "additional_info_contact": "Aydee Crawford\n302-631-6311", "reason_for_recall": "Siemens Healthcare Diagnostics has received complaints of IRON calibrations outside of acceptable calibration slope (m) values (0.97 - 1.03) when using IRON calibrator lots 2DN060 and 2FN063. Lots 2GN068 and 2JN074 may also be impacted but no complaints have been received.", "root_cause_description": "Nonconforming Material/Component", "action": "Siemens sent a \"CUSTOMER NOTIFICATION\" letter dated December 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Siemens Technical Solutions Center at 1-800-441-9250 or your local Siemens Healthcare Diagnostics representative for assistance with this issue.", "product_quantity": "5999", "distribution_pattern": "Nationwide Distribution.", "openfda": { "k_number": [ "K924904", "K022682", "K781853", "K810618", "K921855", "K821938", "K821813", "K951629", "K910721", "K870379", "K925877", "K770072", "K832251", "K840220", "K862704", "K871188", "K821937", "K963847", "K830137", "K001004", "K922646", "K905820", "K951964", "K032697", "K813447", "K011568", "K842450", "K810587", "K822473", "K791315", "K060266", "K032608", "K931834", "K800062", "K002353", "K822232", "K810091", "K010696", "K936201", "K002760", "K013126", "K983640", "K922699", "K861769", "K921903", "K994325", "K821061", "K994114", "K861770", "K801287", "K801501", "K844581", "K861891", "K895778", "K861768", "K012878", "K930477", "K841955", "K760806", "K810742", "K822474", "K001005", "K882726", "K030546", "K823147", "K061251", "K812861", "K822476", "K844235", "K901113", "K871187", "K951585", "K772025", "K030964", "K922698", "K821934", "K852068", "K801665", "K792046", "K813478", "K881693", "K944701", "K822477", "K922696", "K940008", "K884168", "K001002", "K800588", "K840217", "K820698", "K800042", "K871186", "K994169", "K780467", "K872051", "K970933", "K813505", "K895585", "K930501", "K022901", "K802631", "K810963", "K994145", "K905477", "K830283", "K032296", "K003941", "K122126", "K855040", "K810867", "K000331", "K920809", "K862453", "K053104", "K842449", "K810092", "K954546", "K993219", "K994168", "K964475", "K822332", "K932555", "K810743", "K030320", "K800206", "K003969", "K001906", "K871185", "K840299", "K843110" ], "registration_number": [ "2432235", "9612316", "8031673", "3010830834", "1319809", "1318354", "1319808", "2050012", "3012471076", "3005529799", "3010939897", "3013660430", "1827821", "3002642396", "3002809144", "2084025", "3003522182", "3007111389", "3006198300", "3005625991", "3009518015", "3015171822", "1219913", "2431530", "3037000637", "1000403749", "3011989923", "1063851", "3004111573", "3003539867", "3003419906", "9610126", "2122870", "3003561301", "2085064", "1181121", "2245451", "2250051", "1825740", "9680746", "9681753", "3003453957", "3008344661", "8023024", "3004192065", "2517506", "3004529019", "1181055", "3003871639", "9610806", "2247288", "3005146313", "1832216", "3003591759", "9710666", "9610746", "9614373", "3002807722", "3000308930", "3005094123", "3000148879", "1319681", "3005333358", "2434178", "2050010", "1717966", "3012963943", "2030861", "3004493545", "8020316", "3003749380", "1221645", "3016698405" ], "fei_number": [ "3002808328", "2432235", "3002806559", "1000206808", "3002806809", "1318354", "2050012", "3000303338", "3012471076", "3005529799", "3010939897", "3013660430", "1827821", "3002642396", "3002809144", "2084025", "3003522182", "3007111389", "3006198300", "3005625991", "3009518015", "3000215862", "1219913", "2431530", "3037000637", "3015171822", "1000403749", "6387", "3011989923", "3004111573", "3003419906", "2122870", "3003561301", "1000135102", "1181121", "2245451", "2250051", "1825740", "3004525092", "3003453957", "3008344661", "1000136573", "3004192065", "2517506", "3004529019", "1181055", "3003871639", "1000305841", "3005146313", "3003565434", "3002808340", "1832216", "3003591759", "1000305840", "3002807722", "3000308930", "2434178", "3005094123", "3000148879", "3001644026", "2967", "3005333358", "2050010", "1000122044", "1717966", "3012963943", "3004493545", "3006769061", "3002806557", "1000442352", "3003749380", "1221645", "3016698405" ], "device_name": "Calibrator, Primary", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1150", "device_class": "2" } } ] }