{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "218230", "product_res_number": "Z-1370-2026", "event_date_initiated": "2025-12-31", "event_date_posted": "2026-02-13", "recall_status": "Open, Classified", "res_event_number": "98315", "product_code": "CEM", "k_numbers": [ "K021515" ], "product_description": "Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.", "code_info": "Model No. 7303, UDI-DI: 00840095607575, Lot No. 25XXX.", "firm_fei_number": "1220972", "recalling_firm": "Medica Corporation", "address_1": "5 Oak Park Dr", "city": "Bedford", "state": "MA", "postal_code": "01730-1430", "additional_info_contact": "David Hagopian\n781-5417402", "reason_for_recall": "A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica s capillary tubes.", "root_cause_description": "Nonconforming Material/Component", "action": "An URGENT FIELD SAFETY NOTICE was sent to consignees on 01/09/25 informing them that potassium results obtained using affected devices in capillary mode may be falsely elevated. The FSN instructed consignees not to report potassium results obtained in capillary mode using affected lots on the Easy Stat Analyzer. The FSN is to be forwarded to end users and to where product was further distributed. Consignees are to contact their local representative with any questions.", "product_quantity": "1,578 units", "distribution_pattern": "International distribution to the countries of Russia, Bulgaria, Kazakhstan, Ukraine, Pakistan, Belarus.", "openfda": { "k_number": [ "K974784", "K890792", "K915345", "K883240", "K851100", "K840961", "K854298", "K901039", "K840887", "K042270", "K791692", "K060373", "K884769", "K802158", "K915178", "K961115", "K961326", "K844044", "K092686", "K895664", "K870033", "K093318", "K230890", "K830104", "K842786", "K040750", "K932044", "K923038", "K970330", "K900300", "K083680", "K052914", "K842315", "K061107", "K821822", "K112408", "K843239", "K900788", "K833696", "K922943", "K220396", "K832036", "K853356", "K042291", "K092849", "K851808", "K811310", "K790018", "K253491", "K800692", "K912649", "K854723", "K241037", "K896692", "K010061", "K771837", "K800054", "K112412", "K844955", "K121012", "K112995", "K843008", "K844806", "K833776", "K901041", "K851350", "K884566", "K853068", "K841575", "K833159", "K032311", "K870657", "K771118", "K061730", "K843454", "K850950", "K993083", "K112788", "K110520", "K853531", "K915177", "K897110", "K822441", "K073157", "K200544", "K800016", "K791175", "K121040", "K013373" ], "device_name": "Electrode, Ion Specific, Potassium", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1600", "device_class": "2", "registration_number": [ "1827821", "9610633", "2030861", "9614698", "1217183", "1616487", "2939693", "3010324880", "1181121", "3007603826", "3016438761", "3002642396", "3003971136", "1717966", "3007490412", "2517506", "3014607865", "9614673", "3014506106", "2431530", "2432235", "9610529", "3037000637", "3006198300", "3008244372", "8020888", "3002807968", "3003030793", "9680746", "2050010", "1222035", "1319681", "3023268435", "3010825766", "8020316", "3012963943", "1319436", "2050012", "1036362", "9610816", "3004493545", "2245578", "3002807877", "9610126", "3016244760", "1220972", "3003637681", "2250051", "3002637618", "1319809", "3011989923", "9612296", "3000126629", "1000414342", "3000148879", "1219029", "3004378326", "3007662974", "3004102403", "3009473156", "3004438098", "2085064", "3023162659", "3013513377", "3005333358", "3005643513", "3004959793", "8030478", "1000455123", "3005509212", "2247288", "3012817228", "3009156722", "1317202", "3003795116", "3002809144", "1219913", "2221819", "1036223", "1220649", "3003593973", "3000308930", "1000256526" ], "fei_number": [ "1827821", "1000120319", "1217183", "1000305840", "1000206808", "1616487", "2939693", "3010324880", "1181121", "3007603826", "3016438761", "3002642396", "3003971136", "1717966", "3007490412", "2517506", "3014607865", "3014506106", "2431530", "2432235", "3037000637", "3006198300", "3008244372", "3002807968", "3003030793", "3002806560", "3002807167", "2050010", "3002806809", "3007019572", "1222035", "3023268435", "3010825766", "3012963943", "2050012", "3002808382", "1036362", "3001576181", "3004493545", "2245578", "3002807877", "3016244760", "3002806693", "1220972", "3002806559", "3002807663", "3003637681", "2250051", "3002637618", "3011989923", "3000126629", "1000414342", "3000215862", "3000148879", "1219029", "3004378326", "3007662974", "3004102403", "3009473156", "3004438098", "3023162659", "3013513377", "3005333358", "1000135102", "3005643513", "3003559576", "3004959793", "1000136573", "1000455123", "3005509212", "3012817228", "1000122044", "3009156722", "1317202", "3003795116", "3002809144", "1219913", "2221819", "1036223", "1220649", "3003593973", "3000308930", "1000256526" ] } } ] }