{
  "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": "2026-04-22",
    "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": "66842",
      "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": "Telephone",
      "distribution_pattern": "US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.",
      "recall_number": "Z-0547-2014",
      "product_description": "FastPack Total PSA Immunoassay   Chemilunescence assay for the determination of Total PSA.    FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer. The FastPack Total PSA Immunoassay is designed for use with the FastPack System.",
      "product_quantity": "182",
      "reason_for_recall": "Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.",
      "recall_initiation_date": "20131108",
      "center_classification_date": "20131219",
      "termination_date": "20140918",
      "report_date": "20131225",
      "code_info": "Total PSA: Catalog Number 25000040. Lot Number 1309038-10P  Exp Date 6/26/2013."
    }
  ]
}