{
  "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": "193538",
      "product_res_number": "Z-1109-2022",
      "event_date_initiated": "2022-02-15",
      "event_date_created": "2022-05-17",
      "recall_status": "Open, Classified",
      "res_event_number": "90129",
      "product_code": "PEP",
      "k_numbers": [
        "K132843"
      ],
      "product_description": "VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021",
      "code_info": "Lot Number 101321021B",
      "firm_fei_number": "3006028115",
      "recalling_firm": "Luminex Corporation",
      "address_1": "4088 Commercial Ave",
      "city": "Northbrook",
      "state": "IL",
      "postal_code": "60062-1829",
      "additional_info_contact": "Angelo Rago\n512-249-3030 Ext. 9029",
      "reason_for_recall": "Higher than normal \"No Call Internal Control failures\" due to a missing reagent within a small subset of the extraction tray lot.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Luminex sent a product recall notice on 02/15/2022 by email.  The notice informed the user of  \"No Call Internal Control failures\" and requested that they contact Luminex Global Support Services at support@luminexcorp.com to arrange for replacement and confirm the disposal of any kits in inventory.",
      "product_quantity": "984 units",
      "distribution_pattern": "US",
      "openfda": {
        "registration_number": [
          "3005967741",
          "3006413195"
        ],
        "fei_number": [
          "3005967741",
          "3006413195"
        ],
        "device_name": "Molecular Erythrocyte Typing Test",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}