{
  "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": "216570",
      "product_res_number": "Z-0569-2026",
      "event_date_initiated": "2025-10-07",
      "event_date_posted": "2025-11-19",
      "recall_status": "Open, Classified",
      "res_event_number": "97787",
      "product_code": "NJR",
      "k_numbers": [
        "K121044"
      ],
      "product_description": "Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay",
      "code_info": "UDI/DI 00840733102196, Lot Numbers:  480350U020, Exp. 2026-06-12",
      "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 cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Meridian Bioscience issued an \"URGENT MEDICAL DEVICE CORRECTION\" notice to its consignees beginning on 10/15/2025 via email.  The notice explained the problem with the device, health hazard, and requested the following:  \n\"Required Actions: \n\"\tIdentify remaining inventory of Alethia C. difficile, Lot 480050U036. \n\"\tIdentify the Reaction Buffer bag located within the kit box. \n\"\tRemove Reaction Buffer Tubes from Bag and inspect each cap for the presence of a gasket. \n\"\tSegregate Reaction Buffer Tubes which have no gasket present. Record the quantity of tubes with no gasket present on the CONFIRMATION OF NOTIFICATION Form. \n\"\tDiscard Reaction Buffer Tubes which have no gasket present in accordance with local, state, or federal regulations. \nNote: Execution of the test procedure requires the use of a Reaction Buffer tube. The remaining components in this kit may continue to be utilized for patient testing so long as a new Reaction Buffer tube is available. Once the Reaction Buffer is depleted, the remaining kit components must be discarded in accordance with local regulations. \n\"\tMeridian Bioscience Inc. will provide credit for the number of tests impacted. \n\"\tComplete and return the CONFIRMATION OF NOTIFICATION Form to: Product Support Manager, Meridian Bioscience, Inc., 3471 River Hills Drive, Cincinnati, OH 45244; Fax: (513) 272-5432 or Email: FieldActionSupport@meridianbioscience.com.  Complete this form if there is no remaining inventory.\"  \n\nFor any question regarding this notification please call Meridian Bioscience Technical Services at 1-800-343-3858, or email at FieldActionSupport@meridianbioscience.com.",
      "product_quantity": "109 in total",
      "distribution_pattern": "US Distribution to states of: AL, CO, FL, GA, IL, MD, ME, MT, NH, NJ, OH, TN, TX and WA; and OUS (foreign) countries of: Canada, Italy, and Panama.",
      "openfda": {
        "k_number": [
          "K022504",
          "K222638",
          "K173250",
          "K111860",
          "K121044",
          "K062948",
          "K112125",
          "K143312",
          "K133503",
          "K203429",
          "K170557",
          "K060540",
          "K121539",
          "K090191",
          "K181156",
          "K162772",
          "K182467",
          "K173725"
        ],
        "device_name": "Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3740",
        "device_class": "1",
        "registration_number": [
          "1528450",
          "3026312356",
          "3016733849",
          "1524213",
          "3007420875",
          "1119779",
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          "2024800",
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          "3016838963",
          "2023365",
          "3006198300"
        ],
        "fei_number": [
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          "3016733849",
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          "3006198300"
        ]
      }
    }
  ]
}