{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "193171", "product_res_number": "Z-1092-2022", "event_date_initiated": "2022-04-05", "event_date_posted": "2022-05-13", "recall_status": "Open, Classified", "res_event_number": "90023", "product_code": "OOI", "k_numbers": [ "K143653" ], "product_description": "Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system", "code_info": "Serial Numbers for 10-0000-07: 17340003\t19044007\t20133004\t18128002\t18214004\t12061048\t18191010\t13193254\t13051068\t21029902\t16277059\t19233005\t11250096\t14069051\t18255003 *18039010 *20212006 *19317004 *19206009 *18057008\n\nSerial Numbers added 6.23.22 for 10-0000-07R: 18191010 13051068 14069051 *12198198 *12278344 *14322267 *12271338\n\nSerial Numbers added 7.14.22 for 10-0000-07R: 18226007 and 16242043\nSerial Numbers added 7.14.22 for 10-0000-07: 17062030, 18235008 and 19192006", "firm_fei_number": "3002524000", "recalling_firm": "Luminex Corporation", "address_1": "12212 Technology Blvd", "city": "Austin", "state": "TX", "postal_code": "78727-6101", "additional_info_contact": "Luminex Global Support Services\n1877-785-2323", "reason_for_recall": "Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.", "root_cause_description": "Under Investigation by firm", "action": "On 04/21/22 Luminex issued a \"Urgent Medical Device Recall\" Notification to affected consignees. On 6/16/22 and 7/14/22 Luminex expanded the recall to include additional serial numbers. Luminex is asking consignees to take the following actions:\n\n1.\tContinue use of your VERIGENE Processor SP as service has been completed by a Luminex Field Service Engineer and the Processor SP s heaters are now within specification. \n\n2.\tPerform a retrospective review of results for VERIGENE Gram-Positive Blood Culture (BC-GP) and VERIGENE Gram-Negative Blood Culture (BC-GN) Nucleic Acid Tests from 18 months prior to the most recent service visit. Identify any results that were not consistent with other clinical signs and symptoms. Promptly inform Luminex of any previously unreported incidences of false results.\n\n3.\tDistribute the notification to any individuals within your organization who need to be made aware.\n\n4.\tPlease reach out to Global Support Services if a copy of the service record is required.\n\n5.\tPlease complete the Acknowledgement & Receipt form and return within 10 business days.", "product_quantity": "24 units", "distribution_pattern": "US:OH, ME, PA, FL, IL, NE, IN, TX, GA, WA, MI, CO, AZ, OH, KY, CA, VT\nOUS: None", "openfda": { "k_number": [ "K151917", "K102314", "K151690", "K170558", "K092705", "K243922", "K113319", "K220480", "K093383", "K161495", "K222779", "K123955", "K140447", "K160517" ], "registration_number": [ "3012449645", "3012598266", "3019946577", "3004530258", "3009297077", "3019837962", "3043138885", "2024800", "3008318433", "3012494290", "3008754394", "3029059580", "1119779", "3016837106", "3003795116", "3009609218", "3004061467", "3006028115", "3016548670", "3003083993", "3012918440", "3011461582", "3016838963", "3027645317", "3005748784", "3008494306", "3009613136", "3022977716", "3025430789", "3009155756", "3016635427", "3023372670", "1524213", "3007799234", "3003673482", "3011781554", "3002773840", "3003537036", "3016619649", "2022994", "2024674", "3003366417", "3003402518", "3024647994", "1221359", "3043088937", "1650733", "3009984016", "3042971506", "9610240", "3026940910", "3020925311", "3005248192", "3005748564", "3023999024", "3006198300", "1528450", "3007867838", "3012259842", "3009875001", "3003540236", "3003030793", "3009972873", "3007420875", "3009302820", "3004013603", "3004141078", "1550222", "3014325803", "3003018722", "3017644086", "9610126", "2243471", "3007923088", "3005118020", "3014661462", "2023365", "8043379", "3008517993", "3002777243", "3026886124" ], "fei_number": [ "3012449645", "3012598266", "3019946577", "3004530258", "3009297077", "3009391812", "3019837962", "3043138885", "2024800", "3008318433", "3012494290", "1000161215", "3003413192", "3008754394", "3029059580", "1119779", "3016837106", "3003795116", "3009609218", "3004061467", "3006028115", "3016548670", "3003083993", "3012918440", "3011461582", "3016838963", "3027645317", "1000122536", "3005748784", "3008494306", "3009613136", "3022977716", "3025430789", "3009155756", "3002808212", "3016635427", "3023372670", "1524213", "3007799234", "3003673482", "3011781554", "3002773840", "3003537036", "3016619649", "2022994", "2024674", "3003366417", "3003402518", "3024647994", "1221359", "3043088937", "3009984016", "3042971506", "3026940910", "3020925311", "3005248192", "3002524000", "3002806559", "3005748564", "3023999024", "3006198300", "3012259842", "3009875001", "3003540236", "3003030793", "3009972873", "3007420875", "3009302820", "3004013603", "3004141078", "1550222", "3014325803", "3003018722", "3017644086", "2243471", "3007923088", "3014661462", "2023365", "3008517993", "3002777243", "3026886124" ], "device_name": "Real Time Nucleic Acid Amplification System", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2570", "device_class": "2" } } ] }