{
  "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": "204059",
      "product_res_number": "Z-0520-2024",
      "event_date_initiated": "2023-10-19",
      "event_date_posted": "2023-12-08",
      "recall_status": "Open, Classified",
      "res_event_number": "93350",
      "product_code": "IGG",
      "k_numbers": [
        "K792705"
      ],
      "product_description": "Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites\nCatalog Number:  301012",
      "code_info": "UDI-DI: 00840733101250\nLot Numbers: 509130Q\nExpiration Date: 08/11/2025",
      "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": "Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents a risk of\nincidental exposure to biological hazards associated with direct contact with the patient specimen.",
      "root_cause_description": "Process control",
      "action": "Meridan issued Urgent Medical Device Correction letters via email on 10/19/23 to Distributors and End-Users. Letter states reason for recall, health risk and action to take:\nIdentify and segregate any remaining inventory.\nREQUIRED ACTIONS FOR PARA-PAK CLEAN VIAL, CATALOG 900312, LOT 509940Q:\n\" Identify and segregate any remaining inventory.\n\" Discard remaining Inventory of Para-Pak Clean Vial, Catalog 900312, Lot 509940Q in accordance\nwith local, state, and/or federal regulations. Record quantity discarded.\no Contact Meridian Technical Support at 1-800-343-3858 to coordinate product replacement\nactivities.\n\" Complete and return the Customer Notification Form. This will indicate notification of this field\ncorrection. Complete this form even if you have no remaining inventory.\n\nREQUIRED ACTIONS FOR PARA-PAK Zn-PVA/10% FORMALIN, CATALOG 301012, LOT 509130Q:\n\" Identify and segregate any remaining inventory.\n\" For remaining inventory of Para-Pak Zn-PVA/10% Formalin, Catalog 301012, Lot 509130Q, inspect\neach individual vial set for signs of leakage.\no Leakage would be able to be visually observed through inspection of the Ziplock-style bag containing the two vials of preservatives. Signs of leakage include identification of\npreservative outside of the plastic vials or at the bottom of the Ziplock-style bag.\nDO NOT remove vials that exhibit leaking from the Ziplock-style bag. Handle with care to\nprevent direct contact of the preservative with the skin or eyes.\no Record the quantity of 2 vial sets that demonstrated signs of leakage.\n\" Discard the remaining inventory of Para-Pak Zn-PVA/10% Formalin, Catalog 301012, Lot 509130Q in accordance with local, state, and/or federal regulations. Record quantity discarded.\no Contact Meridian Technical Support 1-800-343-3858 to coordinate product replacement activities.\n\" Complete and return the Customer Notification Form. This will indicate notification of this field correction. Complete this form even if you have no remaining invento",
      "product_quantity": "201 Cases",
      "distribution_pattern": "Nationwide\nForeign: Italy",
      "openfda": {
        "k_number": [
          "K771201",
          "K792705",
          "K882268",
          "K861201",
          "K802506",
          "K811794",
          "K792707"
        ],
        "registration_number": [
          "1125908",
          "1831338",
          "1419699",
          "3007496191",
          "3009432145",
          "3006365273",
          "1524213",
          "1625587",
          "1419341",
          "2244900",
          "3010194621",
          "2247035",
          "1045125",
          "1640981",
          "3009963993",
          "3017970519",
          "3008174888",
          "2013736"
        ],
        "fei_number": [
          "1000122268",
          "1419699",
          "1831338",
          "3017970519",
          "3007496191",
          "3006365273",
          "1524213",
          "1625587",
          "3003103936",
          "1419341",
          "2244900",
          "3010194621",
          "1045125",
          "1640981",
          "3009963993",
          "2244894",
          "3008174888",
          "2013736"
        ],
        "device_name": "Formaldehyde (Formalin, Formol)",
        "medical_specialty_description": "Pathology",
        "regulation_number": "864.4010",
        "device_class": "1"
      }
    }
  ]
}