{ "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": 1 } }, "results": [ { "cfres_id": "64693", "product_res_number": "Z-0373-2008", "event_date_initiated": "2007-10-18", "event_date_posted": "2007-12-11", "recall_status": "Terminated", "event_date_terminated": "2008-07-18", "res_event_number": "44972", "product_code": "JGS", "k_numbers": [ "K973292" ], "product_description": "Abbott Point of Care, i-STAT CREA Cartridge (Creatine/Crea); List No: 06F10-01; Part No: 320100; Abbott Point of Care Inc., East Windsor, NJ 08520 USA; Product of Canada.", "code_info": "Catalog Number: 06F10-01; 06F10-02 Lot Numbers: A07149; A07150; G07121; G07148; G07150; G07151; G07151A; G07157; G07158; and G07164A.", "firm_fei_number": "2245578", "recalling_firm": "Abbott Point of Care Inc.", "address_1": "104 Windsor Center Dr", "city": "East Windsor", "state": "NJ", "postal_code": "08520", "additional_info_contact": "609-443-9300", "reason_for_recall": "Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.", "root_cause_description": "Packaging change control", "action": "Abbott Point of Care sent and Urgent Notice to all i-STAT Customers (US and Canadian consignees) notifying them that certain lots of i-STAT cartridges have snap closures that are difficult to close, will not close or do not stay closed. The customers were asked to review the lot numbers on the enclosure and, if the facility has any cartridges from the lot numbers listed, they should remove from service immediately.", "distribution_pattern": "Worldwide Distribution- including USA and country of Canada.", "openfda": { "k_number": [ "K011213", "K963763", "K230275", "K770601", "K830589", "K895936", "K001154", "K830588", "K100829", "K894035", "K961099", "K962334", "K912560", "K864872", "K023049", "K955374", "K941400", "K102647", "K053165", "K904335", "K924471", "K880750", "K870183", "K220977", "K915176", "K863521", "K081411", "K844587", "K924547", "K901042", "K123726", "K172232", "K020364", "K842025", "K992844", "K874185", "K832415", "K000895", "K061597", "K002407", "K892500", "K963542", "K922215", "K940194", "K802155", "K100673", "K850209", "K925612", "K161837", "K872190", "K833992", "K925611", "K811289", "K843453", "K832070", "K840557", "K801882", "K864862", "K121140", "K921718", "K862819", "K841417", "K132418", "K801011", "K002855", "K140373", "K923806", "K853832", "K935120", "K200403", "K181201", "K905264", "K874832", "K873126", "K161954", "K160370", "K800628", "K053110", "K910305", "K252475", "K801896", "K040971", "K833036", "K833072", "K082462", "K863617", "K881255", "K812762", "K213486", "K861967", "K912559", "K222438", "K843452", "K843530", "K810135", "K191365", "K800676", "K841424", "K800216", "K932179", "K151767", "K933373", "K153357", "K052724", "K801007", "K771839", "K912387", "K912648", "K040977", "K992842", "K820395", "K160225", "K896526", "K910554", "K914810", "K903564", "K894218", "K861696", "K875263", "K993211", "K873074", "K852473", "K183549", "K102959", "K880917", "K001761", "K051646", "K180428", "K171476", "K912016", "K832744", "K800584", "K952179", "K990346", "K871028", "K963627", "K852595", "K955375", "K841418", "K822039", "K901040", "K903188", "K882801", "K801795", "K842873", "K895672", "K791691", "K833712", "K844559", "K811896", "K882104", "K863907", "K894914", "K183688", "K921937", "K070104", "K872716", "K933862", "K091861", "K990036", "K905600", "K861087" ], "registration_number": [ "", "9680746", "1000256526", "9610633", "8030478", "2250051", "1220649", "1319809", "2939693", "2245578", "3003637681", "3000308930", "2050012", "3004493545", "1616487", "3013513377", "3010324880", "9614698", "2221819", "1219029", "3002807968", "1317202", "9610126", "3007490412", "1717966", "1219913", "2030861", "3003593973", "8020888", "3003030793", "2431530", "2247288", "3009473156", "3000126629", "1000455123", "3015997711", "3006198300", "1220972", "3004959793", "3023268435", "1319681", "3002809144", "3008244372", "3005643513", "3008629785", "9614673", "1827821", "3000148879", "2517506", "3005509212", "3037000637", "8020316", "3003795116", "3009156722", "3002642396", "1222035", "3002637618", "3010825766", "2432235", "3007662974", "9612296", "3012963943", "9610816", "3016244760", "3011989923", "3004102403", "3004438098", "2050010", "3016438761", "1000414342", "1217183", "1036223", "3023162659", "3014607865", "1036362", "3012104670", "3004378326", "3005333358", "1319436", "3007603826", "1181121", "3012817228", "2085064", "9610529", "3014506106", "3003971136" ], "fei_number": [ "", "1000256526", "2250051", "1220649", "2939693", "2245578", "3003637681", "3003559576", "3000308930", "3002808382", "2050012", "3004493545", "1616487", "3013513377", "3010324880", "1000305840", "2221819", "1219029", "3002806560", "3002807968", "1317202", "3007490412", "1717966", "3002806559", "1219913", "3003593973", "3003030793", "2431530", "3009473156", "3000126629", "1000455123", "3015997711", "3006198300", "1000122044", "1000135102", "1220972", "3004959793", "3023268435", "1000120319", "3002809144", "3008244372", "3005643513", "3008629785", "3002806809", "3002806693", "1827821", "3000148879", "2517506", "3005509212", "3037000637", "3003795116", "3009156722", "3002642396", "1222035", "3002637618", "3010825766", "3007019572", "2432235", "3007662974", "3002807167", "3012963943", "3016244760", "3002807663", "3011989923", "3001576181", "3004102403", "3004438098", "2050010", "3016438761", "1000414342", "1217183", "1036223", "3023162659", "3014607865", "1036362", "1000136573", "3000215862", "3012104670", "3004378326", "1000206808", "3005333358", "3007603826", "1181121", "3012817228", "3014506106", "3003971136" ], "device_name": "Electrode, Ion Specific, Sodium", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1665", "device_class": "2" } } ] }