{
  "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": "Jamestown",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "66916",
      "recalling_firm": "Clark Laboratories, Inc. (dba,Trinity Biotech USA)",
      "address_1": "2823 Girts Road",
      "address_2": "N/A",
      "postal_code": "14701",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA Nationwide Distribution in the state of WA",
      "recall_number": "Z-0572-2014",
      "product_description": "Captia Syphilis-G Test Kit    Product Usage:  This is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in serum specimens, to be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum ( the agent of syphilis). It is also intended for testing of serum or plasma specimens to screen blood and/or plasma donors to exclude a history of syphilis.",
      "product_quantity": "38 kits",
      "reason_for_recall": "Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results.",
      "recall_initiation_date": "20130827",
      "center_classification_date": "20131226",
      "termination_date": "20160524",
      "report_date": "20140101",
      "code_info": "Product Code: 800-960, Lot number: 082, Model: 10 - plate kit",
      "more_code_info": ""
    }
  ]
}