{
  "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": {
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  "results": [
    {
      "cfres_id": "193395",
      "product_res_number": "Z-1050-2022",
      "event_date_initiated": "2022-04-04",
      "event_date_created": "2022-05-06",
      "recall_status": "Open, Classified",
      "res_event_number": "90098",
      "product_code": "QKP",
      "product_description": "Diagnostic Kit SARS-cCo V Antigen Rapid Test",
      "code_info": "Catalog/Model/Part Number: None\nUDI Code:  None\nLot Numbers:  Unknown/None",
      "firm_fei_number": "3021504509",
      "recalling_firm": "USA Medical, LLC",
      "address_1": "1220 Texan Trl Ste 205 1220 Texan Trl",
      "address_2": "Ste 205",
      "city": "Grapevine",
      "state": "TX",
      "postal_code": "76051-4164",
      "additional_info_contact": "817-416-9900",
      "reason_for_recall": "COVID-19/SARS-CoV-2 Antigen Tests did not receive FDA Emergency Use Authorization, nor were the tests cleared or approved to be commercially distributed.",
      "root_cause_description": "No Marketing Application",
      "action": "On 04/04/2022, US Medical LLC sent an \"URGENT MEDICAL DEVICE RECALL\" Letter via certified US Postal informing customers that USA Medical LLC is voluntarily recalling all COVID-19 Rapid test, labeled as  Diagnostic Kit COVID-19 Antigen Rapid Test  and may have included components labeled  DiaTrust COVID-19 Ag Rapid Test.  These COVID-19 antigen tests distributed by USA Medical have not received FDA Emergency Use Authorization, nor have these tests been cleared or approved by FDA for commercial distribution.\n\nCustomers are instructed to:\n1.\tDiscontinue use, discard, or return the product back to USA Medical using the enclosed pre-paid Fed Ex return shipping label.\n2.\tIf you have further distributed these products, immediately notify these customers and provide them with the recall notification.\n3.\tPlease fill out and return that attached Acknowledgement and Receipt Form.\n\nAny further questions or require assistance:  Contact Monday thru Friday 9:00am to 5:00pm Central time at 817-416-9900",
      "product_quantity": "2055 kits",
      "distribution_pattern": "U.S. Nationwide distribution in the states of CA, FL, IN, MD, MO, NJ, OK, and TN.",
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        "device_name": "Coronavirus Antigen Detection Test System.",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "N"
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    }
  ]
}