{ "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": 1 } }, "results": [ { "cfres_id": "149606", "product_res_number": "Z-0100-2017", "event_date_initiated": "2016-07-15", "event_date_created": "2016-10-25", "recall_status": "Terminated", "event_date_terminated": "2017-06-05", "res_event_number": "75186", "product_code": "JJE", "k_numbers": [ "K951595" ], "product_description": "Roche COBAS INTEGRA 800 /800 CTS Analyzer\nAnalyzer, Chemistry (Photometric, Discrete for Clinical use\n\nProduct Usage:\nThe system cobas p612 is a computer-controlled stand-alone system for aliquoting and sorting of barcoded sample tubes. The system operates with an online connection to the host.", "code_info": "Not applicable", "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 C\n800-428-2336", "reason_for_recall": "Roche has received four reports of injury caused by the sharp edge of the center guide rail of an\nanalyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.", "root_cause_description": "Device Design", "action": "On 7/15/2016, URGENT MEDICAL DEVICE CORRECTION notifications were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, an updated cleaning procedure, and instructions for responding to the formal recall notification. Please contact the Roche Support Network Customer Support Center at 1-800-428-2336 if you have questions about the information contained in this UMDC.\n\nOn 10/5/2016, URGENT MEDICAL DEVICE CORRECTION UPDATE notifications were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. The notification updated the 7/15/16 notification to include additional affected systems and to provide updated cleaning instructions for all systems via the enclosed Operators Manual addendum.", "product_quantity": "9014 in total", "distribution_pattern": "US Nationwide Distribution", "openfda": { "k_number": [ "K130915", "K946090", "K833067", "K920402", "K904219", "K830212", "K945271", "K831477", "K843059", "K945135", "K790072", "K883209", "K073370", "K772319", "K910185", "K961481", "K830762", "K063144", "K040958", "K922139", "K800085", "K852133", "K832584", "K890184", "K843283", "K870833", "K893776", "K771245", "K840501", "K842500", "K811194", "K922680", "K782014", "K945566", "K853391", "K890927", "K841916", "K854243", "K771345", "K872105", "K962235", "K883533", "K781076", "K915366", "K854936", "K823386", "K840129", "K943493", "K942443", "K961274", "K842773", "K860748", "K792361", "K881498", "K883321", "K853621", "K950353", "K923579", "K940289", "K863840", "K051087", "K950958", 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