{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "121796", "product_res_number": "Z-0346-2014", "event_date_initiated": "2013-09-03", "event_date_posted": "2013-11-18", "recall_status": "Terminated", "event_date_terminated": "2017-03-07", "res_event_number": "66069", "product_code": "JGS", "product_description": "ADVIA 2400 System Software V4.01.\n\nPerforms assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.", "code_info": "Product Code: 10639265", "firm_fei_number": "2432235", "recalling_firm": "Siemens Healthcare Diagnostics", "address_1": "511 Benedict Ave", "city": "Tarrytown", "state": "NY", "postal_code": "10591-5005", "additional_info_contact": "914-524-2955", "reason_for_recall": "Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA 1200, 1650, 1800 or 2400 Chemistry Systems.", "root_cause_description": "Software design", "action": "On September 3, 2013, Siemens Healthcare Diagnostics issued an Urgent Field Safety Notice for the ADVIA 1200, 1650, 1800 and 2400 Chemistry Systems due to a software issue. The software issue has caused the Chemistry Systems to generate reports without error flags. Notices were sent to domestic customers via U.S. and outside the US the distribution is determined at the country level. The customers were instructed to contact Siemens Healthcare Diagnostics Technical Solution Center if they have technical questions regarding this issue at 877-229-3711 (prompt 18).", "product_quantity": "876 units", "distribution_pattern": "Worldwide Distribution-USA (nationwide) and the countries of Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Vietnam.", "openfda": { "k_number": [ "K921718", "K040977", "K802155", "K020364", "K061597", "K001761", "K053110", "K801795", "K171476", "K842025", "K801882", "K841418", "K903188", "K001154", "K912560", "K100673", "K933862", "K903564", "K990036", "K910554", "K832744", "K935120", "K925612", "K833992", "K895672", "K861967", "K963763", "K933373", "K914810", "K904335", "K091861", "K771839", "K811896", "K932179", "K213486", "K833712", "K922215", "K051646", "K801896", "K820395", "K172232", "K842873", "K161954", "K962334", "K912016", "K905264", "K832415", "K082462", "K852595", "K181201", "K841417", "K791691", "K912387", "K861087", "K200403", "K252475", "K850209", "K880750", "K952179", "K052724", "K841424", "K864862", "K861696", "K863521", "K800628", "K830588", "K222438", "K863907", "K844559", "K840557", "K871028", "K862819", "K800216", "K833036", "K102647", "K151767", "K882801", "K070104", "K801011", "K123726", "K990346", "K894035", "K873126", "K002855", "K910305", "K923806", "K894218", "K940194", "K872190", "K892500", "K801007", "K882104", "K843453", "K880917", "K992844", "K955375", "K811289", "K961099", "K183549", "K843452", "K955374", "K053165", "K963542", "K894914", "K230275", "K875263", "K160225", "K921937", "K872716", "K896526", "K905600", "K924547", "K183688", "K040971", "K100829", "K770601", "K800584", "K844587", "K812762", "K220977", "K800676", "K963627", "K992842", "K915176", "K011213", "K881255", "K912648", "K160370", "K853832", "K874832", "K832070", "K000895", "K901040", "K993211", "K132418", "K941400", "K002407", "K843530", "K925611", "K180428", "K810135", "K833072", "K924471", "K864872", "K121140", "K822039", "K901042", "K102959", "K863617", "K153357", "K873074", "K912559", "K140373", "K830589", "K874185", "K895936", "K191365", "K870183", "K081411", "K161837", "K023049", "K852473" ], "registration_number": [ "", "3003795116", "1827821", "3004102403", "1000414342", "3002809144", "2432235", "1717966", "3009473156", "9610126", "3003637681", "3010324880", "3000308930", "3003030793", "1000256526", "3006198300", "2030861", "3002637618", "3005643513", "2431530", "3012104670", "3004959793", "1000455123", "2050012", "3015997711", "2221819", "1222035", "8020888", "3005509212", "2250051", "9614698", "3008244372", "3007662974", "3007490412", "1616487", "2085064", "3012817228", "1220972", "1036362", "3003593973", "9610633", "1319809", "1217183", "3007603826", "3014607865", "3016438761", "9610816", "3003971136", "3016244760", "3012963943", "3037000637", "3002642396", "3005333358", "3023268435", "9680746", "3004493545", "3002807968", "1317202", "3004378326", "3013513377", "9610529", "2245578", "3014506106", "3010825766", "3023162659", "1219029", "1036223", "2050010", "1220649", "2247288", "1181121", "9614673", "3011989923", "1219913", "1319681", "3009156722", "8030478", "3008629785", "8020316", "9612296", "3004438098", "2939693", "1319436", "3000148879", "2517506", "3000126629" ], "fei_number": [ "", "3003795116", "1827821", "1000122044", "3004102403", "1000414342", "3002809144", "2432235", "1717966", "3009473156", "3003637681", "3010324880", "3000308930", "3003030793", "1000256526", "3006198300", "3002637618", "3005643513", "3003559576", "2431530", "3012104670", "3004959793", "3002807167", "3007019572", "3002807663", "3002806809", "1000455123", "2050012", "3015997711", "1000206808", "2221819", "1222035", "3005509212", "2250051", "3008244372", "3007662974", "3007490412", "1616487", "3012817228", "1220972", "1036362", "3003593973", "1217183", "3007603826", "3002808382", "3014607865", "3016438761", "3003971136", "3016244760", "3012963943", "3037000637", "3002642396", "3005333358", "1000120319", "1000305840", "3023268435", "3002806560", "3000215862", "3004493545", "3002807968", "1000136573", "1317202", "3004378326", "3001576181", "3002806559", "1000135102", "3013513377", "2245578", "3014506106", "3010825766", "3023162659", "1219029", "1036223", "2050010", "1220649", "1181121", "3011989923", "1219913", "3009156722", "3008629785", "3004438098", "2939693", "3002806693", "3000148879", "2517506", "3000126629" ], "device_name": "Electrode, Ion Specific, Sodium", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1665", "device_class": "2" } } ] }