{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "160239",
      "product_res_number": "Z-0606-2018",
      "event_date_initiated": "2017-01-20",
      "event_date_created": "2018-02-14",
      "recall_status": "Terminated",
      "event_date_terminated": "2018-02-20",
      "res_event_number": "78731",
      "product_code": "LSI",
      "product_description": "Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE.  Catalog 200265\n\nIntended for identification of the systemic fungal pathogens.",
      "code_info": "Lot # 5072543 Exp Date 03/12/2021; UDI : 10634853000039.",
      "firm_fei_number": "1050138",
      "recalling_firm": "Gibson Laboratories LLC",
      "address_1": "1040 Manchester St",
      "city": "Lexington",
      "state": "KY",
      "postal_code": "40508-2422",
      "additional_info_contact": "Mrs. Penny B. Epperson\n859-303-5169",
      "reason_for_recall": "The firm information that the product was reporting false positive results",
      "root_cause_description": "Mixed-up of materials/components",
      "action": "On January 20, 2017, the firm sent Urgent Medical Device Recall notification letter and response form to their customers.  The letter identified the affected and the reason for the recall.  Users are instructed not to use any Blastomyces dermatitidis (catalog # 200265) that they may have in inventory and to quarantine any affected product.  Return any affected product per the instructions provided; and, complete and return the attached acknowledgement form.  Questions regarding this recall should be directed to Penny Epperson, Quality Manager, at 859-303-5169 or pepperson@gibsonlabs.com.",
      "product_quantity": "10/1 mL vials",
      "distribution_pattern": "Distributed to the states of AL, AZ & MS.",
      "openfda": {
        "registration_number": [
          "1627497"
        ],
        "fei_number": [
          "1627497"
        ],
        "device_name": "Antiserum, Blastomyces Dermatitidis, Other",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3060",
        "device_class": "2"
      }
    }
  ]
}