{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "184502", "product_res_number": "Z-0477-2021", "event_date_initiated": "2020-10-13", "event_date_created": "2020-11-20", "recall_status": "Terminated", "event_date_terminated": "2024-01-22", "res_event_number": "86124", "product_code": "PEN", "k_numbers": [ "K143653" ], "product_description": "Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. 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unvalidated processes. These text fixtures were used to calibrate and verify VERIGENE SP devices.", "root_cause_description": "Nonconforming Material/Component", "action": "On 10/13/2020, the firm sent the following notice:\n\"As part of our corrective action plan, Luminex will be updating software on all VERIGENE SP instruments in the coming weeks, and systematically visiting every VERIGENE customer site to perform a supplemental preventative maintenance on your instruments. We will also likely be sending out a series of Customer Advisory Notifications with additional information on items related to our remediation efforts surrounding the Warning Letter, as well as updates related to other items identified for improved product performance. During this time, you may continue to use your VERIGENE products as directed in the package inserts for each product, or as otherwise directed through further Luminex communications. \n\nIf you have any question, please do not hesitate to contact Luminex Global Support Services using the contact details below:\nLuminex Global Support Services\n1-877-785-2323 (U.S. and Canada)\n+1-512-381-4397 (Outside U.S. and Canada)\nsupport@luminexcorp.com\"", "product_quantity": "2838 units", "distribution_pattern": "Worldwide distribution. US nationwide and Kuwait, Austria, United Kingdom, Spain, France, Chile, Japan, Netherlands, Greece, Italy, Thailand, Germany, Turkey", "openfda": { "k_number": [ "K243013", "K193519", "K243759", "K130914", "K182619", "K160457", "K143171", "K190341", "K213236", "K181493", "K132843" ], "registration_number": [ "3006028115", "3002773840", "3010749841", "3008632402" ], "fei_number": [ "3006028115", "3002773840", "3010749841", "3008632402" ], "device_name": "Gram-Negative Bacteria And Associated Resistance Markers", "medical_specialty_description": "Microbiology", "regulation_number": "866.3365", "device_class": "2" } } ] }