{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "217467",
      "product_res_number": "Z-1019-2026",
      "event_date_initiated": "2025-12-05",
      "event_date_posted": "2026-01-05",
      "recall_status": "Open, Classified",
      "res_event_number": "98038",
      "product_code": "OZN",
      "k_numbers": [
        "K172569"
      ],
      "product_description": "Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300",
      "code_info": "UDI-DI: 00840733102349;\nLot Numbers: 410300U195, 410300U196, 410300U197, 410300U201",
      "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": "Heather Capito\n800-343-3858",
      "reason_for_recall": "The affected lots show a decline in performance over time, which may lead to false-negative results.",
      "root_cause_description": "Under Investigation by firm",
      "action": "An \"URGENT MEDICAL DEVICE CORRECTION\" dated 12/1/25 was sent to customers.\n\nRequired Actions:\n\" Identify and segregate any remaining inventory of impacted product lots and suspend further use.\n\" Destroy remaining inventory of impacted product lot in accordance with state, local, and/or federal regulations.\no Contact Technical Service for replacement product.\n\" Review previously obtained results from Revogene C. difficile listed Lots numbers. Any negative results obtained should be re-evaluated in conjunction with presented clinical findings to determine if retesting is required.\n\" Complete and return the CONFIRMATION OF NOTIFICATION Form. Complete this form even if there is no remaining inventory.\n\nActions to Be Taken By Meridian Bioscience, Inc.:\nMeridian Bioscience, Inc. will replace any unused inventory and provide support for any\nnecessary retesting, including replacement test materials as needed.\n\nContact Information:\nFor any question regarding this notification please call Meridian Bioscience Technical Service at 1-800-343-3858, or email at FieldActionSupport@meridianbioscience.com.",
      "product_quantity": "211 units",
      "distribution_pattern": "US Nationwide distribution and the OUS country of Italy.",
      "openfda": {
        "k_number": [
          "K172569",
          "K123355",
          "K243730",
          "K132726",
          "K171770",
          "K142422",
          "K170491",
          "K232092",
          "K260045",
          "K130470",
          "K212427",
          "K123998",
          "K163085",
          "K171441",
          "K132235",
          "K123197",
          "K210385",
          "K133936"
        ],
        "device_name": "C. Difficile Toxin Gene Amplification Assay",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3130",
        "device_class": "2",
        "registration_number": [
          "3004141078",
          "3006028115",
          "3004013603",
          "3007420875",
          "2023365",
          "3012918440",
          "2243471",
          "3003795116",
          "1119779",
          "1524213",
          "3012494290",
          "9610126",
          "1528450"
        ],
        "fei_number": [
          "3004141078",
          "3006028115",
          "3004013603",
          "3007420875",
          "2023365",
          "3012918440",
          "2243471",
          "3002806559",
          "3003795116",
          "1119779",
          "1524213",
          "1000122536",
          "3012494290"
        ]
      }
    }
  ]
}