{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "176020", "product_res_number": "Z-0044-2020", "event_date_initiated": "2019-08-13", "event_date_created": "2019-10-04", "recall_status": "Terminated", "event_date_terminated": "2022-06-30", "res_event_number": "83646", "product_code": "JLW", "k_numbers": [ "K162606" ], "product_description": "AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes in human body fluids)\nCatalog Number: 5694302001", "code_info": "Lot Numbers: 18636170 18665170 18667170 18668170 18215274 18245274 18250274 18251274 18252274 18253274 18265274 18271274 19209274", "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 Customer Support Center\n800-428-2336", "reason_for_recall": "AssayTips part of the AssayTip/AssayCup Tray Tips\n used on the cobas e 801 module- may have an Abnormal Internal Structure and lead to Incorrect patient results", "root_cause_description": "Process change control", "action": "Roche Diagnostics issued Urgent Medical Notification letter to Distributor (TP-00744) and end users( TP-00741) on 8/13/19. Letter identifies problem, health risk and Actions required per the UMDC:\n\" Check to see if you have any of the affected lot number(s) of\nAssayTips/AssayCup Trays on your cobas e 801 module or in your laboratory\nstock. (See pictures for lot number locations on packaging.).\n\" Stop using the affected lot number(s) of AssayTips/AssayCup Trays immediately.\n\" Discard the affected lot number(s) of AssayTips/AssayCup Trays according to your local waste management guidelines.\nTo receive replacement product, fill out the attached fax form and fax or email it according to the instructions on the form.\nContact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions", "product_quantity": "935 units", "distribution_pattern": "Nationwide", "openfda": { "k_number": [ "K902333", "K160647", "K912324", "K813645", "K883726", "K780428", "K864079", "K881381", "K871505", "K921958", "K961629", "K890802", "K831972", "K962216", "K001455", "K832499", "K861920", "K923532", "K862428", "K171103", "K770915", "K931061", "K882907", "K943195", "K832462", "K864839", "K770892", "K792443", "K885157", "K821174", "K904666", "K781170", "K923401", "K914756", 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"K772109", "K990993", "K860824", "K861573", "K930006", "K897138", "K880086", "K792562", "K081543", "K101390", "K141999", "K864133", "K843281", "K852438", "K822935", "K942661", "K190773", "K872897", "K933212", "K874061", "K781953", "K883742", "K011527", "K952211", "K900014", "K905769" ], "registration_number": [ "9615037", "3002637618", "9610240", "8020790", "3006677029", "3012073813", "3003795116", "1036362", "1832216", "1827821", "3033967997", "3043127647", "8043909", "3009518015", "2122870", "9612316", "1319808", "1319809", "2030633", "2245285", "2029372", "3009092698", "3005529799", "3002809144", "2432235", "3005360469", "3050015", "3005094123", "3010825766", "2050012", "9613959", "3014279513", "1061124", "9610126", "3022178699", "3012963943", "3007349751", "9614673", "3011989923", "3010421384", "1219913", "8031673", "3009711478", "3010324880", "3002642396", "1319681", "3000308930", "3007111389", "2250051", "3003030793", "3005333358", "3002800697", "2020726", "2032839", 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