{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "184968", "product_res_number": "Z-0755-2021", "event_date_initiated": "2020-12-08", "event_date_created": "2020-12-30", "recall_status": "Open, Classified", "res_event_number": "86981", "product_code": "JJE", "k_numbers": [ "K191899" ], "product_description": "Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units) Chemistry Analyzer (photometric discrete), for clinical use\nPart Number: 05641446001", "code_info": "Serial Numbers: 1925-10; 1931-04; 1931-05;1931-07;1937-10; 1938-01; 1942-10", "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\n317-521-4343", "reason_for_recall": "Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several affected parameters. In the case of poor sample quality, discrepant results may remain undetected due to the absence of associated data flags.", "root_cause_description": "Software design", "action": "Roche recall issued Urgent Medical Device Correction (UMDC TP-01165 and UMDC TP-01169) notifications on 12/8/2020 via UPS Ground (receipt required). Both UMDCs will also be posted to the diagnostics.roche.com website. Letter states reason for recall, health risk and action to take:\nConsignee Instructions:\n Inform any operators who use the cobas 8000 modular analyzer series or the cobas pro integrated solutions of the potential hazards associated with this issue and provide a copy of the UMDC notification, as appropriate.\n Follow the actions outlined in the Customer Actions to Determine if the Issue Has Occurred section of the UMDC.\n Confirm that you have backed up your most recent settings. Repeat this maintenance function whenever a system setting is changed.\n Consult with the physician or pathologist at your facility to determine specific clinical implications for your patients.\n Complete the enclosed faxback form and return it following the instructions on the form.\n File this UMDC for future reference.\n\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 about the information contained in this UMDC.", "product_quantity": "7 units", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K965240", "K862235", "K872494", "K832584", "K003721", "K800572", "K823762", "K890927", "K051087", "K963539", "K961274", "K961142", "K841916", "K073370", "K833833", "K852133", "K823386", "K882307", "K840883", "K040958", "K974779", "K915106", "K864849", "K780464", "K833448", "K854138", "K771245", "K782014", "K834534", "K852262", "K883539", "K942443", "K873617", "K953239", 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