{ "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": "64467", "product_res_number": "Z-0119-2008", "event_date_initiated": "2007-07-18", "event_date_posted": "2007-11-09", "recall_status": "Terminated", "event_date_terminated": "2007-12-13", "res_event_number": "44880", "product_code": "JGS", "k_numbers": [ "K052027" ], "product_description": "OPTI LION E-Plus Cassettes, Model BP7507, (25 per box), In Vitro Diagnostic, OPTI Medical Systems, Inc., Roswell, Georgia 30076", "code_info": "Lot Numbers: 701800, 706800, 710801, 711800, 711801, 712800, 713800, 714800, 714801, 714802, and 718800", "firm_fei_number": "3004102403", "recalling_firm": "Opti Medical Systems Inc", "address_1": "235 Hembree Park Dr Ste 200 235 Hembree Park Dr", "address_2": "Ste 200", "city": "Roswell", "state": "GA", "postal_code": "30076-5700", "additional_info_contact": "Len Owens\n770-510-4444 Ext. 4466", "reason_for_recall": "Incorrect results/stability failure; Actual device stability studies show sodium and chloride sensors age differently than anticipated when stored at the high end of labeled storage, therefore subsequent measurements give results outside the allowed error allowance before the 6 month expiration date shown on the device.", "root_cause_description": "Device Design", "action": "An Urgent Medical Device Recall Letter dated 16 July 2007, was issued via E mail and Fax on/or about 7/18/2007 directing consignees to remove unused cassettes from inventory and destroy them. Replacement cassettes will be shipped upon receipt of information regarding destruction by calling customer service at 800-490-6784. Sub-recall by distributors was requested.", "product_quantity": "289 boxes of 25 cassettes", "distribution_pattern": "Worldwide Distribution-USA, Australia, Chile, China, Egypt, France, Great Britain, Guatemala, Indonesia, Italy, Korea, Lebanon, Mauritania, Morocco, Nepal, Russia, South Africa, Sweden, Tanzania, Thailand, and Venezuela.", "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" } } ] }