{ "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": 19 } }, "results": [ { "cfres_id": "176392", "product_res_number": "Z-0153-2020", "event_date_initiated": "2019-09-11", "event_date_posted": "2019-10-16", "recall_status": "Terminated", "event_date_terminated": "2024-06-11", "res_event_number": "83806", "product_code": "CIG", "k_numbers": [ "K131544" ], "product_description": "Cobas c Bilirubin Total Gen.3\nCatalog Number: 05795419190 - Product Usage: In vitro test for the quantitative determination of the total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems.", "code_info": "Lot # 36133801", "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 Center\n800-428-2336", "reason_for_recall": "Due to low Quality Control recovery and invalid Calibration.", "root_cause_description": "Under Investigation by firm", "action": "1. Discontinue use and discard the remaining affected product in your inventory according to your local waste guidelines.\n\n2. Complete and fax or email the form even if you are not requesting product replacement.\n\nPlease contact the Roche Support Network Customer Support Center 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.\n\nAn Urgent Medical Device Correction letter dated 12/18/19 was sent to customers regarding the expansion of the recall to include an additional lot of Albumin Gen.2 Reagent. \n\nActions Required\n\" Discontinue use and discard the remaining affected product in your inventory according to your local waste guidelines.\n\" Complete the attached fax form (TP-00848) and fax or email it according to the instructions on the form even if you are not requesting product replacement.\n\" File this UMDC for future reference.\nQuestions\nPlease contact the Roche Support Network Customer Support Center 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.", "product_quantity": "2,304 units", "distribution_pattern": "US Nationwide distribution including the states of AL, AZ, CA, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, MI, MO, NE, NH, NJ, NY, OH, OK, PA, PR, RI, SC, TN, TX, UT, VA and WI.\n\nUpdated as of 12/20/19 to include the following additional US states: CO.", "openfda": { "k_number": [ "K861671", "K832942", "K801117", "K251998", "K842385", "K891240", "K810055", "K811881", "K892905", "K891025", "K893730", "K933026", "K885285", "K771092", "K223324", "K841892", "K063543", "K885284", "K863056", "K873424", "K924964", "K932159", "K862359", "K923083", "K003693", "K110780", "K820714", "K770121", "K842809", "K870095", "K821462", "K942999", "K910635", "K930679", "K150510", "K981609", "K840757", "K843178", "K955300", "K863262", "K913307", "K781921", "K981276", "K831843", "K812841", "K902199", "K931888", "K843329", "K040631", "K843032", "K790578", "K881172", "K060574", "K800675", "K781610", "K061830", "K902801", "K923608", "K880396", 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"3004493545", "3012963943", "1616487", "3013513377", "3011989923", "1319681", "3013660430", "9680746", "2050010", "3002809144", "1219029", "3005094123", "3016438761", "3002807968", "1649661", "9610126", "2250051", "3021841051", "3005146313", "1217183", "1827821", "3000148879", "2517506", "3037000637", "8020316", "3003795116", "1319809", "2030861", "1217058", "3003593973", "3002642396", "2939693", "3005333358", "3010825766", "2431530", "1181055", "2432235", "2247288", "1181121", "3007662974", "3000308930", "3006198300", "2085064", "9610529", "1832216", "8040374" ], "fei_number": [ "3006716639", "1000135102", "1220972", "2050012", "3004493545", "3012963943", "1616487", "3013513377", "3011989923", "3013660430", "5864", "1000305840", "2050010", "3002809144", "1219029", "3002806560", "3005094123", "3016438761", "3002807968", "2250051", "3002806809", "3021841051", "3005146313", "1217183", "1827821", "3000148879", "3002806559", "2517506", "3037000637", "3003795116", "1000136573", "1217058", 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