{
  "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": "169846",
      "product_res_number": "Z-0732-2019",
      "event_date_initiated": "2018-12-17",
      "event_date_created": "2019-01-14",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-04-30",
      "res_event_number": "81787",
      "product_code": "MDU",
      "k_numbers": [
        "K904393"
      ],
      "product_description": "PREMIER Cryptococcal Antigen, Catalog Number 602096\n\nProduct Usage:\nThe PREMIER  Cryptococcal Antigen enzyme immunoassay (EIA) is a screening or a semi-quantitative test system for the detection of capsular polysaccharide antigens of Cryptococcus neoformans in serum and cerebrosoinal fluid (CSF).",
      "code_info": "Lot Numbers: 602096K089, 602096K090, 602096K091",
      "firm_fei_number": "1524213",
      "recalling_firm": "Meridian Bioscience Inc",
      "address_1": "3471 River Hills Dr",
      "city": "Cincinnati",
      "state": "OH",
      "postal_code": "45244-3023",
      "additional_info_contact": "Chris Ross\n513-271-3700",
      "reason_for_recall": "An enzyme reagent included in the kit is not maintaining stability through claimed product expiration, resulting in the potential for false negative results when tested with patient specimens and the positive control.",
      "root_cause_description": "Unknown/Undetermined by firm",
      "action": "Urgent: Voluntary Medical Device Recall notification letters dated 12/17/18 were distributed to customers.  The letter identified the affected product, problem and actions to be taken.  The letters instructed customers to review inventory for affected lots, forward the letter to any customers, contact the firm replacement product, complete the response form.  For questions contact Meridian's Technical Service Department by telephone at 800-343-3858 or 513-271-3700 or by  facsimile 513-272-5432.",
      "product_quantity": "184",
      "distribution_pattern": "Worldwide Distribution  - US Nationwide in the states of:  AK, CA, CO, DE, IL, KS, KY, LA, MD, MO, NC, ND, NJ, NY, SC, TX, and VA.\n\nThe products were distributed to the following foreign countries:  India and Italy.",
      "openfda": {
        "k_number": [
          "K904393",
          "K120946"
        ],
        "device_name": "Antigen, Elisa, Cryptococcus",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3165",
        "device_class": "2",
        "registration_number": [
          "2029372",
          "1627497",
          "1524213",
          "3012452932"
        ],
        "fei_number": [
          "1627497",
          "1524213",
          "1000306617",
          "3012452932"
        ]
      }
    }
  ]
}