{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "195665", "product_res_number": "Z-1746-2022", "event_date_initiated": "2021-11-21", "event_date_created": "2022-09-15", "recall_status": "Open, Classified", "res_event_number": "90758", "product_code": "JJH", "product_description": "QIAcube Connect MDx, Model No. 9003070", "code_info": "UDI-DI (GTIN): 04053228039129\nSerial Numbers (U.S.)\n30000 30009 30027 30039 30049 30061 30073\n30002 30010 30028 30041 30050 30062 30075\n30003 30132 30031 30042 30051 30063 30078\n30004 30013 30032 30043 30053 30064 30080\n30005 30016 30034 30044 30057 30065 30082\n30006 30019 30035 30045 30058 30067 30089\n30007 30021 30033 30046 30059 30069 30090\n30008 30023 30037 30047 30060 30071 30093\n30094 30095 30097 30102 30104 30109 30112\n30114 30115 30117 30118 30119 30121 30124\n30127 30128 30129 30130 30131 30133 30134\n30136 30138 30139 30140 30141 30143 30145\n30106 30025 30077 30054 30055 30066 30076", "firm_fei_number": "3003572099", "recalling_firm": "Qiagen Sciences LLC", "address_1": "19300 Germantown Rd", "city": "Germantown", "state": "MD", "postal_code": "20874-1415", "additional_info_contact": "Customer Service\n800-362-7737", "reason_for_recall": "During the \"Load tip racks and enzymes\" step of the run set-up, the info screen indicates \"minimal volume to be loaded\", but the indicated volume is instead the exact volume that should be loaded. Misunderstanding the guidance may lead to over diluted, under diluted, or improperly lysed sample, which in turn could lead to false negative or false positive results.", "root_cause_description": "Other", "action": "Customers were notified of the initial issue by email beginning Nov 3 2021, and\nrequested to return acknowledgment of the notice.\n\nOn January 26, 2022, a new version of the protocol software was released and customers were advised of the new protocol availability and acknowledge download via a follow up notice.", "product_quantity": "93 US; 57 OUS", "distribution_pattern": "Domestic distribution to AZ, CA, CO, DE, DC,\nFL, GA, IA, KS, LA,\nMA, MD, MN, NV, NJ,\nNY, NC, OH, PA, SC,\nSD, TN, TX, VA, WA,\nWI.\n\nInternational distribution worldwide.", "openfda": { "k_number": [ "K893733", "K833919", "K943966", "K851393", "K801772", "K930168", "K941326", "K960298", "K113731", "K871290", "K870690", "K943965", "K770398", "K935496", "K760592" ], "registration_number": [ "3004417597", "9615037", "3009155756", "3016837106", "8030996", "3016733849", "3021043070", "3021269066", "3014290238", "3004013603", "8043909", "3007699074", "3002777243", "1224838", "3013496958", "9610529", "3009238284", "3013540184", "3026035655", "3006198300", "3018771894", "3017583200", "3016764932", "3020925311", "2024800", "3016998616", "3012494290", "3007143373", "2025606", "3010030414", "3010031137", "3006786907", "3005118020", "9615754", "3007420875", "3013756523", "3015980628", "3008517993", "3015529000", "3017098905", "3016068451", "2134567", "3016764493", "3024647994", "3017358793", "3010791816", "3018779125", "3016763307", "3003083993", "3009311010", "3016611336", "3004530258", "3003335080", "3003402518", "3028944399", "9610126", "9612003", "3020831613", "3014325803", "3009207631", "2915796", "3013096769", "3012259842", "1550222", "3005248192", "3015542780", "3019837962", "3007287152", "2030633", "3013548521", "3014100717", "3027518847", "3017170972", "3016635427", "3008937712", "3012101172", "3004141078", "3009573214", "3009443851", "3028240331", "3007808978", "1119779", "3016619649", "3009875001", "3011781554", "3005695808", "1650733", "8043379", "3005748564", "8020892", "3005271071", "3038622676", "3003795116", "3002821232", "3017434950", "3003673482", "3007054022", "3009214950", "3045058049", "3010594620" ], "fei_number": [ "3002622561", "3004417597", "3009155756", "3016837106", "3016733849", "3021043070", "3021269066", "3014290238", "3004013603", "3002808498", "3007699074", "3002777243", "3013496958", "3009238284", "3013540184", "3026035655", "3006198300", "3018771894", "3017583200", "3002806560", "3016764932", "3020925311", "3008237827", "2024800", "3016998616", "3012494290", "3007143373", "2025606", "3010030414", "3010031137", "1318994", "3006786907", "1000513605", "3007420875", "3000210620", "3013756523", "3015980628", "3008517993", "3015529000", "3017098905", "3016068451", "3016764493", "3024647994", "3017358793", "3010791816", "3018779125", "3016763307", "3003083993", "3002524000", "3009311010", "3016611336", "3004530258", "3003335080", "3003402518", "3028944399", "3020831613", "3014325803", "3009207631", "2915796", "3013096769", "3002806559", "3012259842", "1550222", "3005248192", "3015542780", "3019837962", "3007287152", "3013548521", "3014100717", "3027518847", "3017170972", "3016635427", "3008937712", "3004141078", "3009573214", "3009443851", "3028240331", "3003413192", "3007808978", "1119779", "3009875001", "3016619649", "3011781554", "3005695808", "3003261083", "3009391812", "3005748564", "3005271071", "3038622676", "3003795116", "3002807666", "1000532580", "3002821232", "3017434950", "3003673482", "3007054022", "3009214950", "3045058049", "3010594620", "3001421318" ], "device_name": "Clinical Sample Concentrator", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2310", "device_class": "1" } } ] }