{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 6 } }, "results": [ { "cfres_id": "188006", "product_res_number": "Z-2006-2021", "event_date_initiated": "2020-10-30", "event_date_created": "2021-07-02", "recall_status": "Open, Classified", "res_event_number": "88137", "product_code": "OCC", "k_numbers": [ "K143653" ], "product_description": "Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024", "code_info": "030520024A, 030720024A, 031020024A, 031120024A, 031320024A, 031620024C, 031820024A, 031920024A, 032120024A, 032320024A, 032420024A, 032620024A, 033120024A, 040220024A, 040320024A, 040420024A, 040620024A, 040720024A, \n040920024A, 041120024A, 041420024A, 041620024A, 041820024A, 042020024A, \n042120024A, 042320024A, 042520024A, 060320024A, 061320024A, 062320024A, \n070820024A, 071020024A, 072120024A, 072920024A, 080720024A, 081920024A and \n091120024A", "firm_fei_number": "3006028115", "recalling_firm": "Luminex Corporation", "address_1": "4088 Commercial Ave", "city": "Northbrook", "state": "IL", "postal_code": "60062-1829", "additional_info_contact": "LUMINEX Global Support Services\n877-785-2323", "reason_for_recall": "Potential for a false-negative result.", "root_cause_description": "Device Design", "action": "On October 2020 the firm sent a letter to all their consignees with the following information:\n\nDear Valued Luminex Customer,\n\nAccording to our records, you have ordered and may have used our portfolio of VERIGENE Assays in your laboratory. Through post-market surveillance activities, we have identified an increase in the No Call/False Positivity rate for these products. Our investigation has identified that the likelihood of a No Call/False Positive for the assays below increases when test cartridges are left on the Processor SP for an extended time following completion of assay preparation.\n\nWe are currently working on a software solution aimed at further optimizing the washing and drying steps in the sample preparation process. This software update should minimize No Call/False Positive rates for these assays. Until this solution is finalized and implemented, we advise you to remove test cartridges from the VERIGENE SP Processor immediately following completion of assay preparation, and then to process these cartridges on the VERIGENE Reader as soon as possible to obtain test results. While this is common practice for many customers already, doing so should minimize the occurrence of No Call/False Positive results for the products listed below.\n\nWe will contact you with more details on the software solution soon as possible.\n\nPlease contact Luminex Global Support Services with any questions or concerns.\n\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": "38,990", "distribution_pattern": "Worldwide distribution - US Nationwide including in the states of AL, AZ, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA and VT. The countries of Austria, Chile, France, Germany, Greece, Italy, Japan, Kuwait, Netherlands, Spain, Thailand, Turkey, and United Kingdom.", "openfda": { "k_number": [ "K162331", "K231017", "K232775", "K111775", "K172629", "K191729", "K152386", "K123620", "K201505", "K141931", "K143653", "K131813", "K092957", "K120267", "K254139", "K242613", "K200065", "K160068", "K171552", "K193167", "K163636", "K102952", "K161814", "K120413", "K163266", "K073029", "K142365", "K110968", "K103175", "K152523", "K131584", "K081483", "K191534", "K180218", "K103209", "K103776", "K192485", "K153544", "K102170", "K121003", "K112199", "DEN070013", "K170604", "K110764", "K113323", "K132159", "K112781", "K151226", "K112172", "K183597", "K123191", "K181443", "K161375", "K153219", "K163628", "K152579", "K141520", "K093337", "K171792", "K081030", "K121942", "K092500", "K171963", "K091667", "K132129", "K143080", "K151464", "K173932", "K111387", "K152408", "K210234", "K171974", "K083088", "K213822", "K142045", "K161220", "K092566", "K162456", "K181289" ], "registration_number": [ "3005248192", "1650733", "3003030793", "3007799234", "2023365", "3019946577", "3012494290", "3008632402", "3021140368", "3009613136", "3004141078", "3023372670", "3002777243", "1528450", "3013019728", "3023999024", "3002773840", "3005360469", "3010749841", "3038610665", "3003018722", "9681630", "3029059580", "2243471", "9610126", "3006028115", "3004530258", "3006198300", "2024800", "1221359", "3010770794", "3003795116", "3016838963" ], "fei_number": [ "3005248192", "3002806559", "3003030793", "3007799234", "3005670738", "2023365", "3019946577", "3012494290", "3008632402", "3021140368", "3002808845", "3009613136", "3004141078", "1000122536", "3023372670", "3002777243", "3013019728", "3023999024", "3002773840", "3010749841", "3038610665", "3003018722", "3029059580", "2243471", "3006028115", "3004530258", "3006198300", "2024800", "1221359", "3002524000", "3010770794", "3003795116", "3016838963" ], "device_name": "Respiratory Virus Panel Nucleic Acid Assay System", "medical_specialty_description": "Microbiology", "regulation_number": "866.3980", "device_class": "2" } } ] }