{ "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": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "199211", "product_res_number": "Z-1394-2023", "event_date_initiated": "2023-03-08", "event_date_posted": "2023-04-17", "recall_status": "Open, Classified", "res_event_number": "91917", "product_code": "OUG", "product_description": "AQURE REF 933-599\nSoftware Versions \n2.5.2\n2.5.3\n2.5.4\n2.6.0\n2.6.1\nThe AQURE system is intended to let you manage analytical devices and operator profiles.\nThe user can associate patient data with test data. The system shows test results. The\nsystem receives data from connected devices at the point-of care or laboratory. It can send test results to the HIS/LIS. The system lets you send commands to selected devices. The system uses data related to the performance of devices, to tell users of issues to be\nmanaged. The AQURE system is intended for professional use.", "code_info": "Model Number: 933-599\nUDI-DI Code: 05700699335999\nSoftware Versions: 2.5.2 and above (Versions 2.5.2, 2.5.3, 2.5.4, 2.60, and 2.6.1)", "firm_fei_number": "3002807968", "recalling_firm": "Radiometer Medical ApS", "address_1": "Akandevej 21 21 akandevej", "city": "Bronshoj", "country": "Denmark", "additional_info_contact": "Technical Support, Radiometer America Inc. \n800-736-0600 Ext. 1", "reason_for_recall": "Due to potential software issue that may result in patient mix-up information.", "root_cause_description": "Software design", "action": "On 03/08/2023, the firm sent an \"Urgent: Medical Device Recall\" letter via email and FedEx to customers informing them that there is a potential software issue that may result in patient information mix-up when connected to the LumiraDx device. This may potentially result in a patient with critically or life-threatening elevated levels of D-dimer or NT-pro-BNP being diagnosed with levels within the normal range.\n\nCustomers are instructed to perform:\n1) With immediate effect, cease using the LumiraDx devices if connected with an AQURE system with the affected software versions:\n2.5.2,\n2.5.3, \n2.5.4\n2.6.0\n2.6.1\n2) Within two weeks of receipt of this letter, complete and email a copy of the Recall Response Form and return it to a Radiometer Representative.\n\nA Radiometer Representative will contact and schedule a visit or remote session to:\n\" If you use LumiraDx devices connected with AQURE, your AQURE system must be upgraded. Your local Radiometer representative will contact you when a solution is available.\n\" If you do not use LumiraDx devices, your Radiometer representative will contact you and remove the LumiraDx driver from the AQURE system, hence preventing the usage of LumiraDx devices in context with your current AQURE system(s).\n\nFor questions, contact Radiometer at 1-800-736-0600, Monday - Friday 9 am to 7 pm (EST).", "product_quantity": "1,806 systems", "distribution_pattern": "Worldwide - U.S. Nationwide including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of Argentina, Australia, Austria, Bahrain, Brazil, Chile, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Iraq, Israel, Italy, Japan, Jordan, Kuwait,\nLebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Paraguay, Peru, Poland, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay.", "openfda": { "k_number": [ "K122361" ], "registration_number": [ "", "2183449", "3002806740", "3016053964", "3021038030", "3009137498", "3030265385", "3017415521", "2086725", "3005439497", "3015316279", "3013501110", "3004070020", "3012164459", "1528142", "8010177", "9617474", "3016727307", "3029300449", "3042852637", "9611451", "3009144084", "3013059683", "3027502949", "3009632672", "3014926240", "1220648", "9615102", "3009486782", "3015802419", "2020676", "3009715978", "3013896610", "3008881835", 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