{ "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": "150124", "product_res_number": "Z-0387-2017", "event_date_initiated": "2016-09-27", "event_date_posted": "2016-11-10", "recall_status": "Terminated", "event_date_terminated": "2017-07-21", "res_event_number": "75357", "product_code": "JJE", "k_numbers": [ "K071211" ], "product_description": "Roche COBAS INTEGRA c111\nAnalyzer, Chemistry (Photometric, Discrete), for clinical use\n\nProduct Usage:\nThe Roche COBAS INTEGRA c111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically. The analyzer also has an optional ISE module for measuring sodium, potassium and chloride.", "code_info": "04777433001 Cobas c111 with ISE 04528778001 Cobas c111 without ISE  cobas c 111 analyzers (catalog numbers 04777433001 and 04528778001) with software versions up to and including 4.20", "firm_fei_number": "1823260", "recalling_firm": "Roche Diagnostics Operations, Inc.", "address_1": "9115 Hague Rd", "city": "Indianapolis", "state": "IN", "postal_code": "46256-1025", "additional_info_contact": "Roche Support Network Customer Support C\n800-428-2336", "reason_for_recall": "cobas c 111 analyzers (catalog numbers 04777433001 and\n04528778001) with software versions up to and including 4.20 may encounter the following alarm:\n7002: 108000572, A software error occurred. This alarm is generated due to a measurement timing\nerror. Under very rare conditions, the instrument may process two tests in the same cuvette if the run\nrestarts. If a used cuvette is used again result of the test(s) will be erroneous.\nThese erroneous results may not be flagged.\nFalsely low or high patient results may lead to incorrect diagnostic measures and medical therapeutic\ndecisions. The medical risk depends on the parameter.", "root_cause_description": "Software design", "action": "Roche sent an URGENT MEDICAL DEVICE CORRECTION letter dated September 27, 2016 to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers were asked to complete the attached fax form and fax it to 1-866-808-1159. For questions contact the Roche Support Network Customer Support Center at 1-800-428-2336.", "product_quantity": "139", "distribution_pattern": "US Nationwide Distribution", "openfda": { "k_number": [ "K130915", "K946090", "K833067", "K920402", "K904219", "K830212", "K945271", "K831477", "K843059", "K945135", "K790072", "K883209", "K073370", "K772319", "K910185", "K961481", "K830762", "K063144", "K040958", "K922139", "K800085", "K852133", "K832584", "K890184", "K843283", "K870833", "K893776", "K771245", "K840501", "K842500", "K811194", "K922680", "K782014", "K945566", "K853391", "K890927", "K841916", "K854243", "K771345", "K872105", "K962235", "K883533", "K781076", "K915366", "K854936", "K823386", "K840129", "K943493", "K942443", "K961274", "K842773", "K860748", "K792361", "K881498", "K883321", "K853621", "K950353", "K923579", "K940289", "K863840", "K051087", "K950958", "K810549", "K133519", "K840868", "K884378", "K833833", "K923060", "K885226", "K834521", "K974651", "K883539", "K872494", "K860021", "K950915", "K810129", "K872302", "K833116", "K931744", "K974779", "K113253", "K830318", "K831649", "K881495", "K872104", "K860647", "K930489", "K820687", "K894222", "K840120", "K903071", "K962125", "K864849", "K893137", "K882913", "K874857", "K885289", "K915106", "K800053", "K882914", "K962231", "K870836", "K933703", "K820118", "K882559", "K970227", "K760642", "K933548", "K862818", "K922072", "K863531", "K854138", "K002982", "K890929", "K971761", "K131554", "K853699", "K884035", "K830301", "K832115", "K855196", "K965240", "K904220", "K801889", "K912844", "K983345", "K841076", "K851638", "K890928", "K821335", "K885288", "K860080", "K844114", "K770679", "K953239", "K852262", "K926060", "K942364", "K854025", "K922220", "K802609", "K023764", "K772344", "K843610", "K931786", "K802835", "K893547", "K882451", "K902689", "K823762", "K963539", "K813102", "K780083", "K865105", "K882194", "K882081", "K800572", "K873130", "K912024", "K813160", "K890183", "K822465", "K940810", "K781528", "K944093", "K924084", "K901003", "K183375", "K791297", "K882307", "K872813", "K902336", "K803267", "K833448", "K951189", "K861055", "K841503", "K901346", "K810596", "K791296", "K882450", "K944028", "K873617", "K003721", "K042169", "K872103", "K832648", "K942922", "K921661", "K780464", "K130276", "K811919", "K803135", "K834534", "K840883", "K961142", "K873749", "K895423", "K843082", "K010500", "K802320", "K831518", "K862235", "K780388", "K112999", "K853003", "K820888", "K110035" ], "pma_number": [ "P910007" ], "registration_number": [ "", "3014717638", "3020978007", "3008517993", "3007118747", "3008425728", "3012526002", "3015969360", "3003589956", "9680746", "3003917514", "2182595", "3005094123", "1931251", "1000256526", "2435505", "1424235", "8030478", "2250051", "3008494306", "2027969", "3003741796", "3005342322", "2915796", "1319809", "2016473", "3004145393", "2245578", "3003637681", "3017098905", "2523553", "3027977508", "3000308930", "3042244350", "3005529799", "1832216", "3002889627", "3006716639", "2050012", "3004493545", "2032900", "1616487", "3030493719", "9614373", "3010324880", "3013660430", "3003542872", "9614698", "9615754", "2221819", "3009238284", "1219029", "3004434309", "3009518015", "3007208259", "3042177088", "3006677029", "1317202", "9610126", "3005748564", "9610942", "3003268355", "3007361513", "3030234142", "3010610113", "1717966", "3021394862", "1219913", "2030861", "3003593973", "8020888", "3007111389", "3007500635", "3003030793", "3005655287", "3008853996", "3033967997", "2431530", "3008576040", "3009473156", "3017548799", "1000455123", "3008344661", "3006198300", "2122870", "9610806", "1220972", "3009297077", "3009711478", "3023268435", "1319681", "1415939", "3005622096", "2915274", "1319808", "3002809144", "3003559191", "3011179004", "3008244372", "3004529019", "3005643513", "2026994", "9614673", "2020726", "9615037", "1827821", "3000148879", "2517506", "3017894300", "3005509212", "3037000637", "8020316", "3003795116", "3011061417", "3009156722", "3010031137", "3012057020", "2032839", "3002642396", "3042268054", "3014643041", "3014150341", "3010825766", "2432235", "3003402518", "3007662974", "9612296", "9610566", "3012963943", "3016244760", "3011989923", "3017019647", "3004102403", "3035708936", "3004438098", "3014325803", "2050010", "1643621", "3014353045", "8043379", "3002895169", "3016438761", "9615056", "3007135420", "8031673", "3009984016", "9610240", "1217183", "1036223", "3044473429", "3023162659", "9681753", "3010421384", "3012471076", "3014607865", "1036362", "9613959", "3004378326", "3034707949", "3005333358", "8021924", "1319436", "3029973107", "3002806944", "3005748784", "3007603826", "9615837", "1181121", "3004973408", "3014840402", "2085064", "8023060", "9610529", "2247288" ], "fei_number": [ "", "3014717638", "3020978007", "3008517993", "3007118747", "3008425728", "3012526002", "3015969360", "3003589956", "1000125787", "3000303338", "3003917514", "2182595", "3005094123", "1931251", "1000256526", "2250051", "3008494306", "3008237827", "3003741796", "3005342322", "2915796", "3004445302", "3004145393", "2245578", "3003637681", "3017098905", "2523553", "3027977508", "3003559576", "3000308930", "3002808382", "3042244350", "3005529799", "1832216", "3002889627", "3006716639", "2050012", "3004493545", "1616487", "3030493719", "3010324880", "3013660430", "3003542872", "1000305840", "2221819", "3009238284", "1219029", "3004434309", "3002806560", "3009518015", "3042177088", "3007208259", "3006677029", "1317202", "2967", "3005748564", "3003268355", "3007361513", "3030234142", "3010610113", "1717966", "3021394862", "3002806559", "1000186023", "1219913", "3003593973", "3007111389", "3007500635", "3003030793", "3005655287", "3008853996", "3033967997", "2431530", "3008576040", "3002807876", "3009473156", "3017548799", "1000455123", "3008344661", "1000125596", "3006198300", "2122870", "1000122044", "1000135102", "1220972", "3009297077", "3009711478", "3023268435", "3003992026", "1415939", "3002808340", "3005622096", "1000120319", "2915274", "3002809144", "3003559191", "3011179004", "3008244372", "3004529019", "3005643513", "3003413192", "3002806809", "2026994", "1000119795", "2020726", "1827821", "3000148879", "2517506", "3017894300", "3005509212", "3002608770", "3037000637", "3003795116", "3011061417", "3009156722", "3010031137", "3012057020", "3002642396", "3042268054", "3014643041", "3002485711", "3014150341", "3010825766", "3007019572", "2432235", "3002808212", "3003402518", "3007662974", "3007262384", "3004185580", "3012963943", "3016244760", "3002807663", "3011989923", "3017019647", "3001576181", "3004102403", "3035708936", "3004438098", "3014325803", "2050010", "1643621", "3014353045", "3001075266", "3002895169", "3016438761", "3007135420", "3002808301", "3009984016", "1217183", "1036223", "3003261083", "3044473429", "3023162659", "3010421384", "3012471076", "3014607865", "1036362", "1000136573", "1000305841", "3000215862", "3004378326", "3001644026", "1000206808", "3034707949", "3005333358", "3005748784", "3029973107", "3002806944", "3007603826", "1181121", "3004973408", "3014840402" ], "device_name": "Analyzer, Chemistry (Photometric, Discrete), For Clinical Use", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2160", "device_class": "1" } } ] }