{
  "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": {
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    {
      "cfres_id": "194270",
      "product_res_number": "Z-1401-2022",
      "event_date_initiated": "2022-06-15",
      "event_date_created": "2022-07-29",
      "recall_status": "Open, Classified",
      "res_event_number": "90381",
      "product_code": "QKP",
      "product_description": "SARS CoV 2 rapid antigen test kits packaged under the following brands:\nOral Rapid Test, Oral Rapid Antigen Test, SML LDT Kits, SML Brand Finished Kits, SML Brand BT Test Kits, SML Brand BT Antigen Test Kit LDT",
      "code_info": "Lot:  FLUSA 1020-1, Batches 8, 10, and 12",
      "firm_fei_number": "3021477751",
      "recalling_firm": "North American Diagnostics",
      "address_1": "618 Ridgewood Ave",
      "city": "Holly Hill",
      "state": "FL",
      "postal_code": "32117-3604",
      "reason_for_recall": "Various brands of SARS CoV  2 Antigen Rapid Test kits were offered for sale and distribution to consumers in the United States without marketing approval, clearance, or authorization from FDA.",
      "root_cause_description": "No Marketing Application",
      "action": "The firm initiated their recall by email on 06/15/2022.  The letter explained the issue and requested the consignee take the following actions:\n\"\" Immediately destroy all unused product to North American Diagnostics Inc.\n\" Immediately identify all affected product in your inventory and segregate to avoid\ninadvertent use or further distribution.\n\" Complete the attached response form and return it to Elizabeth Lashinsky\nealash52@gmail.com.\n\" If you have further distributed any of these products, please notify your customers\nimmediately with a copy of this notice, and please request that your customers destroy\nany product they may have in inventory and confirm in writing that they have done so.\n\" If you have relabeled the product prior to distributing it, please indicate the number below and the name on the label.\nIf you have questions or concerns regarding this recall, or problems with the product, please contact Elizabeth A. Lashinsky, Manager, ealash52@gmail.com, 407-312-7104.",
      "product_quantity": "122,366 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of  FL, LA, NV, CA, CO, AZ, CT, OH. IL, NY, DC, MD, PA, and the countries of Zambia, Austria, Canada, UAE, Bangladesh.",
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        "device_name": "Coronavirus Antigen Detection Test System.",
        "medical_specialty_description": "Unknown",
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        "device_class": "N"
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