{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
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  "results": [
    {
      "cfres_id": "196943",
      "product_res_number": "Z-0323-2023",
      "event_date_initiated": "2022-08-09",
      "event_date_posted": "2022-12-07",
      "recall_status": "Open, Classified",
      "res_event_number": "91137",
      "product_code": "QBD",
      "product_description": "Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B",
      "code_info": "LOT / EXP\nDW200628   27-Jun-21\nDW200520   19-May-21\nDW200520   19-May-21\nDW201202   01-Dec-21\nDW201202   1-Dec-21\nDW210103   2-Dec-22\nDW210926   25-Sep-22",
      "firm_fei_number": "3016853433",
      "recalling_firm": "DEWEI MEDICAL EQUIPMENT CO LTD",
      "address_1": "5 Th Floor No.4 Building Shiyou Industrial Park",
      "address_2": "5 Th Floor",
      "city": "Foshan",
      "country": "China",
      "reason_for_recall": "Products were distributed in the United States without FDA authorization or clearance.",
      "root_cause_description": "No Marketing Application",
      "action": "Starting on August 9, 2022, the firm contacted its customers through instant messaging to inform them that the affected products were not authorized, cleared, or approved by the FDA. Distributors were asked to cease selling and distributing the affected kits in U.S. immediately.\n\nOn August 19, 2022, the firm followed up with its customers with an email stating the same.\n\n\nThe firm has ceased exporting the DNA/RNA Preservation kits to the U.S. \n\nIf you have any questions, email: sherry@deweilab.com.",
      "product_quantity": "1,348,000 (US)",
      "distribution_pattern": "US Distribution in states to: CA, FL, KY, and MI.",
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        "device_name": "Microbial Nucleic Acid Storage And Stabilization Device",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.2950",
        "device_class": "2",
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