{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "168971", "product_res_number": "Z-0652-2019", "event_date_initiated": "2018-10-19", "event_date_created": "2018-12-20", "recall_status": "Terminated", "event_date_terminated": "2022-01-24", "res_event_number": "81563", "product_code": "JJE", "k_numbers": [ "K083173" ], "product_description": "VITROS 3600 Immunodiagnostic System, Version 3.3.1 & below\n\n For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.", "code_info": "Product Code: 6802783 UDI 10758750002979  Product Code: 6802914  UDI 10758750007103  Serial Numbers: J36000109-J36001169", "firm_fei_number": "1000136573", "recalling_firm": "Ortho-Clinical Diagnostics", "address_1": "100 Indigo Creek Dr", "city": "Rochester", "state": "NY", "postal_code": "14626-5101", "additional_info_contact": "Ortho Care Technical Solutions\n800-421-3311", "reason_for_recall": "Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.", "root_cause_description": "Software Manufacturing/Software Deployment", "action": "On October 19, 2018, Ortho Clinical Diagnostics issued \"URGENT PRODUCT CORRECTION NOTIFICATION\" notices via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers to inform them of the issue and actions to take to prevent occurrence of the anomaly. On November 19, 2018 Ortho Clinical Diagnostics re-issued correction notices to customers pertaining to the 5,1 FS system (CL2018-194_5,1FS). Customers may continue using their VITROS Systems and have been informed that the software issue will be mitigated with the next version of software. The expected dates of these software versions are included in the communication. \n\nForeign affiliates were informed by email approximately on 21 October 2018 of the issue and instructed to notify their consignees of the issue and required actions to prevent the occurrence of the anomaly.\n\nPlease refer to the Customer letter (Ref. CL2018-194_51FS, CL2018-194_3600, CL2018-194_4600, and CL2018-194_5600) for specific details on Required Actions by User. \n\nIf you have further questions, please contact Ortho Care\" Technical Solutions Center at 1-800-421-3311.", "product_quantity": "682", "distribution_pattern": "US Nationwide Distribution", "openfda": { "k_number": [ "K873130", "K971761", "K882081", "K802609", "K840501", "K882559", "K861055", "K780083", "K840129", "K772319", "K841916", "K831649", "K930489", "K863531", "K830762", "K860647", "K883209", "K953239", "K802835", "K965240", "K945271", "K110035", "K042169", "K073370", "K970227", "K813160", "K926060", "K842500", "K823386", "K002982", "K832648", "K800053", "K853003", "K931744", "K843283", "K800572", "K950353", "K924084", "K843059", "K844114", "K885226", "K843082", "K130276", "K923579", "K893776", "K832584", "K942364", "K131554", "K912844", "K931786", "K782014", "K821335", "K933548", "K780388", "K860748", "K950958", "K923060", "K833116", "K862235", "K903071", "K855196", "K950915", "K922220", "K884378", "K831518", "K051087", "K820888", "K974651", "K833067", "K853391", "K872494", "K852262", "K915366", "K771245", "K010500", "K872103", "K870836", "K983345", "K864849", "K840883", "K840868", "K800085", "K890928", "K830301", "K853621", "K890927", "K865105", "K894222", "K842773", "K890184", "K770679", "K944093", "K882307", "K810596", "K883539", "K063144", "K872105", "K942443", "K962125", "K860080", "K820687", "K840120", "K961481", "K884035", "K893547", "K901003", "K843610", "K940810", "K910185", "K801889", "K803135", "K863840", "K872104", "K862818", "K811919", "K771345", "K921661", "K833833", "K885289", "K882914", "K912024", "K963539", "K961274", "K872302", "K870833", "K803267", "K881498", "K883321", "K922072", "K933703", "K944028", "K890183", "K851638", "K854243", "K885288", "K902336", "K962235", "K841503", "K860021", "K760642", "K791297", "K790072", "K003721", "K040958", "K962231", "K831477", "K112999", "K772344", "K113253", "K841076", "K882451", "K820118", "K895423", "K130915", "K882450", "K901346", "K873749", "K874857", "K873617", "K945566", "K830318", "K942922", "K781528", "K945135", "K854025", "K781076", "K854936", "K872813", "K802320", "K833448", "K780464", "K852133", "K832115", "K946090", "K853699", "K915106", "K810129", "K834521", "K902689", "K904220", "K940289", "K922680", "K881495", "K823762", "K974779", "K904219", "K920402", "K882194", "K890929", "K854138", "K951189", "K882913", "K810549", "K813102", "K133519", "K883533", "K943493", "K023764", "K811194", "K834534", "K792361", "K183375", "K822465", "K893137", "K961142", "K922139", "K830212", "K791296" ], "pma_number": [ "P910007" ], "registration_number": [ "", "2027969", "2432235", "3021394862", "2182595", "3030234142", "8043379", "3017019647", "3005529799", "9610806", "3002809144", "3007111389", "3006198300", "2915274", "3037000637", "3027977508", "3014840402", "1036362", "3042268054", "3009297077", "1036223", "2085064", "3008494306", "3005509212", "1181121", "2016473", "3030493719", "3023162659", "3007118747", "2517506", "3017548799", "3005748784", "3007603826", "3000308930", "3020978007", "3005094123", "1319681", "1643621", "3007135420", "2050010", "2030861", "3003795116", "3005342322", "8023060", "9610566", "3017894300", "1319809", "3008853996", "2221819", "9614673", "3023268435", "3034707949", "3007500635", "1319808", "3006716639", "3009984016", "3003559191", "9615754", "3009518015", "3009156722", "3011989923", "1000256526", "3002895169", "2122870", "3005655287", "3002806944", "3010610113", "3035708936", "9681753", "2245578", "3004378326", "1415939", "9610942", "3004529019", "3007361513", "1832216", "3014353045", "3008517993", "8020888", "3004434309", "3004102403", "3005333358", "3014325803", "3012963943", "3004493545", "3003268355", "9615037", "3008244372", "3010825766", "3008425728", "3003030793", "2026994", "8031673", "3014150341", "2020726", "9615837", "2050012", "3012471076", "1424235", "9613959", "3013660430", "3029973107", "1931251", "3011061417", "3008576040", "3002642396", "3004973408", "3005643513", "1219913", "3005622096", "1616487", "3007208259", "9610126", "3007662974", "3010421384", "1317202", "3014643041", "3009238284", "8021924", "2250051", "3011179004", "3042177088", "3004145393", "3008344661", "3006677029", "3003589956", "2247288", "3009711478", "8030478", "9610240", "3012057020", "9612296", "3014717638", "2435505", "3003593973", "9614698", "3044473429", "2032839", "2523553", "9610529", "3004438098", "1319436", "3002889627", "3015969360", "1219029", "1220972", "3042244350", "3017098905", "2032900", "1827821", "3003402518", "3010031137", "9615056", "2431530", "3005748564", "3014607865", "3009473156", "1000455123", "3003542872", "9680746", "3012526002", "3003741796", "3003637681", "3016438761", "1217183", "2915796", "3010324880", "9614373", "3000148879", "1717966", "8020316", "3003917514", "3016244760", "3033967997" ], "fei_number": [ "", "3003992026", "2432235", "1000120319", "3021394862", "2182595", "3030234142", "1000206808", "3017019647", "3007262384", "3005529799", "3002809144", "3007111389", "3006198300", "2915274", "3037000637", "3027977508", "3008237827", "3014840402", "1036362", "3001576181", "3042268054", "3009297077", "1036223", "3008494306", "1000135102", "3005509212", "1181121", "1000119795", "3030493719", "3023162659", "3007118747", "3004445302", "2517506", "3017548799", "3005748784", "3007603826", "3000308930", "3020978007", "3005094123", "1643621", "3007135420", "2967", "2050010", "3003795116", "3005342322", "3017894300", "2221819", "3008853996", "3023268435", "3034707949", "3007500635", "3006716639", "3009984016", "3003559191", "3009518015", "3009156722", "3011989923", "1000256526", "3003559576", "3002895169", "2122870", "3005655287", "3002806944", "3010610113", "3035708936", "2245578", "3004378326", "1415939", "3004529019", "3007361513", "1832216", "3014353045", "3008517993", "1000305840", "3004434309", "3002808212", "3004102403", "3003261083", "1000122044", "3005333358", "1000125596", "3014325803", "3012963943", "3004493545", "3003268355", "3008244372", "3010825766", "3007019572", "3008425728", "3003030793", "2026994", "3002806559", "3014150341", "2020726", "2050012", "3012471076", "3002807663", "3013660430", "3029973107", "1931251", "3011061417", "3008576040", "3002642396", "3004973408", "3005643513", "1219913", "3005622096", "1616487", "3007208259", "3007662974", "3010421384", "1317202", "3014643041", "3009238284", "2250051", "3011179004", "3042177088", "3004145393", "3008344661", "3006677029", "1000125787", "3003589956", "3009711478", "3002808340", "3012057020", "3014717638", "3001644026", "3044473429", "3003593973", "3001075266", "2523553", "3004438098", "3002808301", "3002889627", "3015969360", "1219029", "1220972", "3042244350", "3002806809", "3000303338", "3017098905", "1827821", "3002608770", "3003402518", "3010031137", "3000215862", "3003413192", "2431530", "3005748564", "3014607865", "3002485711", "3004185580", "3009473156", "1000455123", "3002806560", "3003542872", "3012526002", "3003741796", "1000136573", "3003637681", "3016438761", "1000305841", "1217183", "2915796", "3010324880", "3000148879", "1717966", "3003917514", "3002808382", "3016244760", "3002807876", "1000186023", "3033967997" ], "device_name": "Analyzer, Chemistry (Photometric, Discrete), For Clinical Use", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2160", "device_class": "1" } } ] }