{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Carlsbad",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85134",
      "recalling_firm": "Qualigen Inc",
      "address_1": "2042 Corte Del Nogal",
      "address_2": "N/A",
      "postal_code": "92011-1438",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Nationwide distribution in the states of AL, AK, CA, HI, and TX.",
      "recall_number": "Z-1672-2020",
      "product_description": "The FastPack System Comlete Immunoassay Kit    Immunoassay for the Quantitative Measurement of SHBG is a chemiluminescent immunoassay intended for the quantitative determination of Sex Hormone Binding Globulin in human serum and plasma on the FastPack System.  The FastPack IP SHBG assay is intended for use as an aid in the diagnosis of androgen disorders.    Each Kit Contains  30 FastPack IP SHBG Immunoassays  1 Calibrator 1 x 3 mL Vial  1 Control 1 1 x 3 mL Vial  1 Control 2 1 x 3 mL Vials  32 Sample Diluent 0.9 mL Vials    REF 25000081  IVD  CE    1908038-1P  2020-02-22  (01) 20816467020345  (17) 200222  (10) 1908038-1P",
      "product_quantity": "24 Kits (30 test packs each)    720 tests",
      "reason_for_recall": "The chemiluminescent immunoassay has been noted to have higher than expected results which may result in inaccurate quantitative determinations of Sex Hormone Binding Globulin in human serum and plasma.",
      "recall_initiation_date": "20191106",
      "center_classification_date": "20200406",
      "termination_date": "20200923",
      "report_date": "20200415",
      "code_info": "1908038-1P  2020-02-22  (01) 20816467020345  (17) 200222  (10) 1908038-1P"
    }
  ]
}