{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "211243",
      "product_res_number": "Z-0805-2025",
      "event_date_initiated": "2024-12-03",
      "event_date_posted": "2025-01-03",
      "recall_status": "Open, Classified",
      "res_event_number": "95807",
      "product_code": "CDZ",
      "k_numbers": [
        "K182521"
      ],
      "product_description": "The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in human serum and plasma. For in vitro diagnostic Use and contains 30 FastPacks.",
      "code_info": "UDI-DI: 20816467020345, Lot numbers: 2408018-1 Exp: 2025-09-05; 2409015-1, Exp: 2025-06-27; and 2409015-2, Exp: 2025-06-26.",
      "firm_fei_number": "3003355251",
      "recalling_firm": "Qualigen Inc",
      "address_1": "2042 Corte Del Nogal",
      "address_2": "Ste B",
      "city": "Carlsbad",
      "state": "CA",
      "postal_code": "92011-1438",
      "additional_info_contact": "Erin Hoffman\n760-5796900 Ext. 267",
      "reason_for_recall": "Three lots of the FastPacks kitted into the FastPack SHBG Complete Kits were labeled with the incorrect expiration date. The following is a listing of affected lots: Lot Number: 2408018-1, 2409015-1, and 2409015-2. The likelihood of patient harm is expected to be low as routine Quality Control should detect kits that are impacted by signal deterioration due to age.",
      "root_cause_description": "Labeling Change Control",
      "action": "The recalling firm issued letters dated 11/19/2024 via email to their customers explaining the reason for recall and providing the correct expiration dates for each of the affected lot numbers.  The risk to health was provided and instructions given to be completed.  The instructions were to cease use of the affected product, dispose of all remaining kits from the affected lot numbers, document the number of kits disposed, complete the acknowledgment form by FAX or email within 5 days.",
      "product_quantity": "426",
      "distribution_pattern": "Distribution was made to AR, CA, CO, FL, IL, IN, MA, MO, NC, NY, OH, OK, TN, TX, and VA.  There was no military/government/foreign distribution.",
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        "device_name": "Radioimmunoassay, Testosterones And Dihydrotestosterone",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1680",
        "device_class": "1"
      }
    }
  ]
}