{
  "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": "2026-04-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Jamestown",
      "state": "NY",
      "country": "United States",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "69827",
      "recalling_firm": "Clark Laboratories, Inc. (dba,Trinity Biotech USA)",
      "address_1": "2823 Girts Rd",
      "address_2": "N/A",
      "postal_code": "14701-9666",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "New York, Florida, Utah, and California plus foreign distribution to Spain and France",
      "recall_number": "Z-0819-2015",
      "product_description": "Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diagnostic use; an antibody class capture enzyme immunoassay for the detection of IgM antibodies to T. pallidum as an aid to the identification of active syphilis in human serum.",
      "product_quantity": "Domestic: 9 kits; Foreign: 26 kits",
      "reason_for_recall": "Through in-house routine real time stability monitoring of Trinity's Captia Syphilis IgM Capture Test Kit, Lot 033, the firm identified a failure of the kit to meet its labeled expiry dating of 6 months.",
      "recall_initiation_date": "20141117",
      "center_classification_date": "20141216",
      "termination_date": "20160524",
      "report_date": "20141224",
      "code_info": "Lot 033, expiry date 30 November 2014"
    }
  ]
}