{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Norman",
      "state": "OK",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "89370",
      "recalling_firm": "Immuno-Mycologics, Inc",
      "address_1": "2701 Corporate Centre Dr",
      "address_2": "N/A",
      "postal_code": "73069-2901",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Nationwide distribution in the states of  AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WA.",
      "recall_number": "Z-0545-2022",
      "product_description": "CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum and CSF, REF  CR2003, IVD, UDI:  (01)00816387020919",
      "product_quantity": "411 kits",
      "reason_for_recall": "The firm found immunoassay products used to detect cryptococcal antigen in serum and cerebrospinal fluid to have reduced specificity (90% now versus 99% before). As a result, a small number of samples with positive test results may be false positives, which may cause some patients to initiate unnecessary anti-fungal therapy.  Samples with negative test results are NOT affected.",
      "recall_initiation_date": "20220103",
      "center_classification_date": "20220131",
      "termination_date": "20240515",
      "report_date": "20220209",
      "code_info": "F1021035 and F1021036"
    }
  ]
}