{
  "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,
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  "results": [
    {
      "status": "Terminated",
      "city": "Indianapolis",
      "state": "IN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "84840",
      "recalling_firm": "Polymer Technology Systems, Inc.",
      "address_1": "7736 Zionsville Rd",
      "address_2": "N/A",
      "postal_code": "46268-2175",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Domestic distribution nationwide. Foreign distribution to Belgium, South Africa, South Korea, and Poland.",
      "recall_number": "Z-1438-2020",
      "product_description": "PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The PTS Detect cotinine system provides quantitative measurement of the nicotine metabolite cotinine (25 200 ng/mL) in capillary (fingerstick) or venous whole blood. The test is for professional use to determine if an individual has been exposed to nicotine.",
      "product_quantity": "6790",
      "reason_for_recall": "The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.",
      "recall_initiation_date": "20200121",
      "center_classification_date": "20200304",
      "termination_date": "20201214",
      "report_date": "20200311",
      "code_info": "1811715  1831313  1831324  1831325"
    }
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}