{
  "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": "25556",
      "product_res_number": "Z-0463-03",
      "event_date_initiated": "2002-12-26",
      "event_date_posted": "2003-01-23",
      "recall_status": "Terminated",
      "event_date_terminated": "2004-03-29",
      "res_event_number": "25295",
      "product_code": "MCB",
      "k_numbers": [
        "K926442"
      ],
      "product_description": "Premier brand C. difficile Toxin A, diagnstic test kits, one kit per pouch, one pouch per shipping box.",
      "code_info": "Lot #601096.180, Exp Date 27 SEP 03;   Kit Catalog #601096.",
      "firm_fei_number": "1524213",
      "recalling_firm": "Meridian Bioscience Inc",
      "address_1": "3471 River Hills Dr",
      "city": "Cincinnati",
      "state": "OH",
      "postal_code": "45244",
      "reason_for_recall": "Due to defective packaging, the firm cannot assure product stability through the labeled expiration date.",
      "root_cause_description": "Other",
      "action": "The firm mailed notices to their affected customers on 12/26/2002.  The consignees were instructed to visually and physically inspect the seals on each microwell pouch for gaps.  If properly sealed, the use of the microwells may be continued.  Test wells in pouches with defective seals are to be quarantined and destroyed.  The customers are asked to report back to the firm.  All test microwell plates in defective pouches will be replaced by the firm.",
      "product_quantity": "1,215 kits",
      "distribution_pattern": "The kits were distributed to end-users and distributors located nationwide;  and to foreign distributors located in China, Guatemala, New Zealand, Hong Kong, Mexico, Great Britain, Belgium, Italy, Brazil, Australia, Canada, Thailand, Honduras, and Japan.",
      "openfda": {
        "k_number": [
          "K110620",
          "K833447",
          "K955067",
          "K904329",
          "K924062",
          "K112048",
          "K895915",
          "K053572",
          "K132010",
          "K974881"
        ],
        "device_name": "Antigen, C. Difficile",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.2660",
        "device_class": "1",
        "registration_number": [
          "3009935129",
          "1528450",
          "2182595",
          "1524213",
          "8020790",
          "1122855",
          "9615056",
          "3004569406"
        ],
        "fei_number": [
          "3009935129",
          "1000611339",
          "2182595",
          "1524213",
          "1000122536",
          "1000123404",
          "1000186023",
          "3004569406"
        ]
      }
    }
  ]
}