{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "190460",
      "product_res_number": "Z-0382-2022",
      "event_date_initiated": "2021-10-11",
      "event_date_created": "2021-12-15",
      "recall_status": "Terminated",
      "event_date_terminated": "2023-03-09",
      "res_event_number": "89088",
      "product_code": "MJH",
      "k_numbers": [
        "K991074"
      ],
      "product_description": "Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's Disease by qualitative detection of Legionella Pneumophila seragroup 1 antigen in human urine.\nProduct Code: B1029-440",
      "code_info": "Lot # 056 \nExpiration Date: 2022-11-28\nUDI: 05391516744065",
      "firm_fei_number": "1318354",
      "recalling_firm": "Clark Laboratories, Inc.",
      "address_1": "2823 Girts Rd",
      "city": "Jamestown",
      "state": "NY",
      "postal_code": "14701-9666",
      "additional_info_contact": "SAME\n716-483-3851",
      "reason_for_recall": "Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay",
      "root_cause_description": "Material/Component Contamination",
      "action": "Trinity Biotech notified customers by Customer Recall  letter dated 10/11/21 states reason for recall, health risk and action to take: \nCustomers are instructed to complete the attached fax back form indicating how many of this kit lot you have in your inventory and you will receive replacement from another lot.\nA thorough investigation into the root cause has been initiated and any corrective/preventive actions will be implemented as appropriate.\nIf you have any questions or comments arising from this customer communication, the Trinity Biotech Help Desk is ready to answer your questions (800-325-3424, option 2).\nto destroy the kit and offered replacement product of a different lot. Any results\nobtained from a valid assay may be reported do not require repeat testing.",
      "product_quantity": "53 units",
      "distribution_pattern": "OH, UT",
      "openfda": {
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          "K934965",
          "K191184",
          "K070522",
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          "K163273",
          "K911356",
          "K061496",
          "K982238",
          "K113190"
        ],
        "registration_number": [
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          "3006224287",
          "1000306617",
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          "3017662853",
          "3007361513"
        ],
        "device_name": "Legionella, Spp., Elisa",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3300",
        "device_class": "2"
      }
    }
  ]
}