{
  "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": "Miami",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "63410",
      "recalling_firm": "Diamedix Corporation",
      "address_1": "2140 N. Miami Avenue",
      "address_2": "N/A",
      "postal_code": "33127",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - USA Nationwide including the  states: CA, ID, NJ, NY, OH, PA, PR, RI, TN, and TX,  FL, and the countries of Italy, Chile and Ecuador",
      "recall_number": "Z-0445-2013",
      "product_description": "The Is-anti-Sm test kits****Catalog No: 720-240***  Product Usage:  The Diamedix Is-anti-Sm Test Kit is an EIA procedure intended for the detection and semi-quantitation of antibodies against the Sm antigen in serum as an aid in the diagnosis of autoimmune disease. The results are reported in ELISA units (EU) per ml determined by comparison to a Calibrator.",
      "product_quantity": "65 Test Kits",
      "reason_for_recall": "Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification.",
      "recall_initiation_date": "20120806",
      "center_classification_date": "20121127",
      "termination_date": "20140808",
      "report_date": "20121205",
      "code_info": "Catalog # 720-240,  Lot # T0401, Expiration Date: November 18. 2012"
    }
  ]
}