{ "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": "129802", "product_res_number": "Z-0064-2015", "event_date_initiated": "2014-09-12", "event_date_posted": "2014-10-10", "recall_status": "Terminated", "event_date_terminated": "2018-01-10", "res_event_number": "69173", "product_code": "CHL", "k_numbers": [ "K032311" ], "product_description": "Omni Micro-electrode/reference electrode for cobas b221 analyzer.\r\n\r\nThe Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate.", "code_info": "Model/Catalog/Part Number: 1. 03337103001 2. 03337111001 3. 03337154001 4. 03337138001 5. 03337120001 6. 03337146001 7. 03337111692 8. 03337138692 9. 03337154692", "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": "Todd Siesky\n317-576-2000 Ext. 249", "reason_for_recall": "The default references for normal values are inconsistent between cobas b 221 and other blood gas instruments. In addition, the reference ranges are different when comparing with corresponding ranges listed in the Instructions for Use for the analyzer and the reference literature source.", "root_cause_description": "Labeling Change Control", "action": "The Urgent Medical Device Correction will be sent via UPS Ground (receipt required) to the consignee list. The Urgent Medical Device Correction will be sent via UPS Ground (receipt required) to the consignee list.\r\n\r\nConsignees are instructed as follows:\r\n\" Check the current set of reference values on your cobas b 221 blood gas system and, if appropriate, change the reference ranges accordingly.\r\n\" If you have not established your own reference ranges, please follow the instructions in the Workaround section of the UMDC or contact the Roche Support Network Customer Support Center.", "product_quantity": "492 devicees", "distribution_pattern": "Nationwide Distribution including Puerto Rico and Guam, and the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, ME, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA and WI.", "openfda": { "k_number": [ "K946206", "K840468", "K050423", "K914560", "K122729", "K844781", "K831021", "K831016", "K970710", "K932642", "K771253", "K760969", "K823750", "K980130", "K810724", "K934907", "K973367", "K980991", "K771822", "K935830", "K813517", "K240998", "K953935", "K820744", "K852790", "K142220", "K173403", "K021515", "K924497", "K954612", "K151978", "K160412", "K922922", "K831025", "K080370", "K991417", "K093280", "K021713", "K840843", "K012478", "K831010", "K940918", "K943882", "K031560", "K882941", "K842519", "K014295", "K903965", "K820597", "K760229", "K022746", "K110648", "K831379", "K100777", "K130144", "K122539", "K000103", "K844295", "K860057", "K133407", "K223857", "K962021", "K831017", "K160153", "K173797", "K850360", "K954482", "K151982", "K041874", "K002738", "K812090", "K882209", "K840300", "K823570", "K904188", "K831015", "K863880", "K002613", "K984384", "K051804", "K193246", "K935655", "K990092", "K963964", "K881188", "K111897", "K922631", "K993789", "K954711", "K800224", "K992859", "K871397", "K890827", "K012058", "K915087", "K200986", "K913927", "K760748", "K131126", "K831024", "K792230", "K891578", "K854608", "K936203", "K043218", "K873577", "K834601", "K884143", "K955793", "K200107", "K945240", "K192240", "K131988", "K980523", "K982928", "K122642", "K800271", "K961657", "K244014", "K812552", "K942616", "K821483", "K924758", "K833534", "K023567", "K943570", "K812623", "K961335", "K831019", "K944089", "K895317", "K002290", "K110416", "K832779", "K142898", "K865036", "K831023", "K200492", "K895181", "K963800", "K211559", "K853405", "K935069", "K832981", "K131703", "K772307", "K982277", "K013729", "K831020", "K852676", "K831013", "K120197", "K992834", "K935121", "K833536", "K904513", "K864445", "K841609", "K252207", "K853840", "K810308", "K936081", "K771147", "K203790", "K151856", "K914166", "K020297", "K230285", "K141907", "K063376", "K781968", "K111188", "K902267", "K943643", "K780716", "K061974", "K884267", "K974526", "K800757", "K123748", "K974396", "K221900", "K770736", "K223608", "K961161", "K831012", "K994346", "K831018" ], "device_name": "Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1120", "device_class": "2", "registration_number": [ "3002637618", "1220972", "3005643513", "3013513377", "3003795116", "1036362", "2431530", "3004102403", "9610633", "1217183", "3012104670", "2245578", "3004959793", "1000455123", "3014506106", "2432235", "1717966", "2050012", "3023162659", "3015997711", "1219029", "3003971136", "9610126", "1220649", "1181121", "1222035", "3037000637", "1219913", "8030478", "3007662974", "3007490412", "3002807968", "3012817228", "3006198300" ], "fei_number": [ "3002637618", "1220972", "3005643513", "3013513377", "3003795116", "1036362", "2431530", "3004102403", "1217183", "3012104670", "2245578", "3004959793", "1000455123", "3014506106", "2432235", "1717966", "2050012", "3023162659", "3015997711", "1219029", "3003971136", "1220649", "1181121", "1222035", "3037000637", "1219913", "3007662974", "3007490412", "3002806693", "3002807968", "3012817228", "3006198300", "3001576181", "3002806559" ] } } ] }