{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "124185",
      "product_res_number": "Z-0572-2014",
      "event_date_initiated": "2013-08-27",
      "event_date_posted": "2013-12-26",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-05-24",
      "res_event_number": "66916",
      "product_code": "LIP",
      "product_description": "Captia Syphilis-G Test Kit\r\n\r\nProduct 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.",
      "code_info": "Product Code: 800-960, Lot number: 082, Model: 10 - plate kit",
      "firm_fei_number": "1318354",
      "recalling_firm": "Clark Laboratories, Inc. (dba,Trinity Biotech USA)",
      "address_1": "2823 Girts Road",
      "city": "Jamestown",
      "state": "NY",
      "postal_code": "14701",
      "additional_info_contact": "716-483-3851",
      "reason_for_recall": "Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results.",
      "root_cause_description": "Process design",
      "action": "Trinity Biotech issued an Urgent Product Information Request letter to their customer on August 27, 2013.  The letter identified the affected product, problem and actions to be taken.  The request was to determine if their customer did or did not backfill microtiter-strips during the analytical process.  If a customer backfilled, they were advised to return the completed request form.  On September 11, 2013 Trinity Biotech issued a notice to their customers advising them to re-evaluate any negative patient results for those who perform backfilling.  For questions contact Trinity Biotech Help Desk at 800-325-3424, option 2.",
      "product_quantity": "38 kits",
      "distribution_pattern": "USA Nationwide Distribution in the state of WA",
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        "device_name": "Enzyme Linked Immunoabsorption Assay, Treponema Pallidum",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3830",
        "device_class": "2"
      }
    }
  ]
}