{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 36 } }, "results": [ { "cfres_id": "29699", "product_res_number": "Z-0060-04", "event_date_initiated": "2003-09-22", "event_date_posted": "2003-10-24", "recall_status": "Terminated", "event_date_terminated": "2004-02-04", "res_event_number": "27334", "product_code": "CHL", "k_numbers": [ "K981427" ], "product_description": "Stat Profile Ultra Magnesium Sensor (In-vitro Diagnostic used with the Stat Profile Ultra M analyzer)\nPart # 20394", "code_info": "Lot Number Exp. Date\t 304716\t\t2/29/04 \t\t 304074\t\t2/29/04\t\t 303798\t\t1/31/04\t\t 303515\t\t1/31/04\t\t 303479\t\t1/31/04\t\t 303222\t\t1/31/04\t\t 302808\t\t12/31/03\t\t 302652\t\t12/31/03\t\t 302267\t\t12/31/03\t\t 301844\t\t11/30/03\t\t 301443\t\t11/30/03\t\t 301219\t\t11/30/03\t\t 212490\t\t10/31/03\t\t 212332\t\t10/31/03\t\t 212043\t\t10/31/03\t\t 211170\t\t9/30/03", "firm_fei_number": "1219029", "recalling_firm": "Nova Biomedical Corporation", "address_1": "200 Prospect Street", "city": "Waltham", "state": "MA", "postal_code": "02454", "additional_info_contact": "Paul MacDonald\n781-647-3700 Ext. 211", "reason_for_recall": "Degradation of the magnesium sensor could result in low ionozed magnesium patient samples", "root_cause_description": "Other", "action": "Nova Biomedical contacted customers by telephone beginning on 9/26/03. Each account was faxed or mailed Customer Information Bulletin requesting the discard of Mg++ sensors in inventory that are greater than 4 months old from date of manufacture. Replacement product will be issued.", "product_quantity": "659 units", "distribution_pattern": "Natinwide\nForeign: Italy, Czech, Japan, Taiwan, Hungary, India, Israel, Mexico, Canada, Germany,Switzerland, Tunisia, Korea, Brazil, Greece, Coatia, China, France, Turkey, Thailand, Argentina.\nGovernment: VA Decator, GA", "openfda": { "k_number": [ "K990092", "K771253", "K854608", "K770736", "K833534", "K831025", "K962021", "K934907", "K844295", "K974396", "K932642", "K961335", "K812090", "K884267", "K771147", "K200986", "K994346", "K831012", "K760229", "K240998", "K832779", "K935655", "K002613", "K882941", "K051804", "K810724", "K842519", "K200492", "K110416", "K110648", "K852676", "K924497", "K173403", "K884143", "K151978", "K812552", "K122539", "K813517", "K993789", "K823570", "K831015", "K940918", "K050423", "K935121", "K002290", "K820744", "K223857", "K904513", "K954612", "K151982", "K122642", "K833536", "K221900", "K173797", "K021713", "K820597", "K973367", "K936081", "K914166", "K881188", "K000103", "K133407", "K865036", "K974526", "K841609", "K831020", "K945240", "K831379", "K013729", "K853840", "K873577", "K943643", "K924758", "K151856", "K871397", "K922922", "K902267", "K041874", "K021515", "K020297", "K111897", "K955793", "K980523", "K942616", "K760969", "K963964", "K043218", "K992834", "K890827", "K844781", "K122729", "K831019", "K831018", "K831010", "K230285", "K953935", "K831013", "K863880", "K935830", "K831021", "K160153", "K904188", "K014295", "K142898", "K991417", "K992859", "K100777", "K944089", "K834601", "K022746", "K895317", "K772307", "K831016", "K831017", "K961161", "K111188", "K760748", "K891578", "K192240", "K131126", "K943882", "K780716", "K012058", "K840843", "K800757", "K821483", "K012478", "K914560", "K810308", "K131988", "K850360", "K023567", "K852790", "K895181", "K080370", "K131703", "K970710", "K980991", "K831023", "K946206", "K963800", "K031560", "K203790", "K961657", "K913927", "K984384", "K853405", "K130144", "K141907", "K936203", "K832981", "K840300", "K860057", "K093280", "K200107", "K142220", "K922631", "K211559", "K831024", "K982277", "K252207", "K980130", "K882209", "K800224", "K792230", "K864445", "K812623", "K954711", "K954482", "K943570", "K063376", "K840468", "K915087", "K903965", "K061974", "K160412", "K935069", "K223608", "K002738", "K823750", "K800271", "K193246", "K123748", "K244014", "K120197", "K771822", "K781968", "K982928" ], "device_name": "Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1120", "device_class": "2", "registration_number": [ "2050012", "1220972", "3004959793", "3013513377", "3004102403", "1219029", "3005643513", "3002807968", "9610633", "8030478", "9610126", "3007490412", "1217183", "1717966", "3023162659", "1220649", "1219913", "3037000637", "3003795116", "1036362", "3012104670", "1222035", "3002637618", "2245578", "2431530", "2432235", "1181121", "3007662974", "1000455123", "3015997711", "3012817228", "3006198300", "3014506106", "3003971136" ], "fei_number": [ "2050012", "1220972", "3004959793", "3013513377", "3001576181", "3004102403", "1219029", "3005643513", "3002807968", "3002806693", "3007490412", "1217183", "1717966", "3002806559", "3023162659", "1220649", "1219913", "3037000637", "3003795116", "1036362", "3012104670", "1222035", "3002637618", "2245578", "2431530", "2432235", "1181121", "3007662974", "1000455123", "3015997711", "3012817228", "3006198300", "3014506106", "3003971136" ] } } ] }