{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "214604",
      "product_res_number": "Z-2292-2025",
      "event_date_initiated": "2025-07-22",
      "event_date_posted": "2025-08-12",
      "recall_status": "Open, Classified",
      "res_event_number": "97117",
      "product_code": "MJH",
      "k_numbers": [
        "K991074"
      ],
      "product_description": "Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440.\r\n\r\nIn Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires  Disease.",
      "code_info": "Model Number: B1029-440. UDI-DI: 05391516744065. Lot Numbers: 065 and 066",
      "firm_fei_number": "1318354",
      "recalling_firm": "Trinity Biotech USA",
      "address_1": "2823 Girts Rd",
      "city": "Jamestown",
      "state": "NY",
      "postal_code": "14701-9666",
      "reason_for_recall": "Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Trinity Biotech initially notified consignees 06/05/2025 via letter. Consignees were instructed to inspect the conjugate bottles before use in both manual and automated testing and if any are observed with particulate matter, Trinity Biotech confirms the kit performs, and results are consistent with release specifications and IFU claims.  However, replacement can be requested.\n\nTrinity Biotech notified consignees again on about 07/22/2025 via an updated URGENT: MEDICAL DEVICE Notification letter.  Consignees were instructed that their trained laboratory technicians should inspect the conjugate bottles before use in both manual and automated testing, if any bottle is observed to contain conjugate with particulate matter, to discard the bottle and use a clear bottle available. If there are no other available clear bottles, please contact Trinity Biotech for a replacement kit. The current conjugate will be replaced with Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 067 once available.",
      "product_quantity": "968 kits",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of Maryland and Utah.  The countries of France, Germany, Ireland, Israel, Kuwait, Latvia, UK.",
      "openfda": {
        "k_number": [
          "K934965",
          "K191184",
          "K982238",
          "K033051",
          "K061496",
          "K070522",
          "K163273",
          "K991074",
          "K911356",
          "K113190"
        ],
        "registration_number": [
          "1318354",
          "3007361513",
          "3017662853",
          "3007118747",
          "1924669",
          "3003268355",
          "9611882",
          "3005984081",
          "3003750284",
          "1221359",
          "2245285",
          "8010096",
          "2029372",
          "3043196750",
          "3002800697",
          "1524213",
          "1645225"
        ],
        "fei_number": [
          "1318354",
          "3006224287",
          "3007361513",
          "3017662853",
          "3007118747",
          "1924669",
          "3003268355",
          "3005984081",
          "1000118544",
          "1221359",
          "2245285",
          "3003750284",
          "3043196750",
          "3002800697",
          "1000306617",
          "1524213",
          "3002808078"
        ],
        "device_name": "Legionella, Spp., Elisa",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3300",
        "device_class": "2"
      }
    }
  ]
}