{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "195445",
      "product_res_number": "Z-1524-2022",
      "event_date_initiated": "2022-07-14",
      "event_date_created": "2022-08-17",
      "recall_status": "Open, Classified",
      "res_event_number": "90698",
      "product_code": "QJR",
      "product_description": "ARIES SARS-CoV-2 Assay",
      "code_info": "Lot: AB4042A",
      "firm_fei_number": "3002524000",
      "recalling_firm": "Luminex Corporation",
      "address_1": "12212 Technology Blvd",
      "city": "Austin",
      "state": "TX",
      "postal_code": "78727-6101",
      "additional_info_contact": "512-219-8020",
      "reason_for_recall": "SARS-CoV-2 assay that detects SARS-CoV-2 ORF1ab and N genes may not detect the ORF1ab gene. A positive results if either SARS-CoV-2 genes is detected, but If both genes are mistakenly not detected, a false negative result would be generated.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "On 7/14/22 recall notices were emailed to consignees who were asked to review any results from the affected lot to confirm the validity of the results. In addition, all remaining cassettes from this lot should be discarded.\nCustomers with questions are encouraged to contact the firm at: 1-877-785-2323 (U.S. and Canada), +1-512-381-4397 (Outside U.S. and Canada), support@luminexcorp.com",
      "product_quantity": "257",
      "distribution_pattern": "U.S. Nationwide distribution in the states of NE, TX, MS, TN, KY, ME, CA.",
      "openfda": {
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        ],
        "device_name": "Reagents, 2019-Novel Coronavirus Nucleic Acid",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "N"
      }
    }
  ]
}