{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "193261",
      "product_res_number": "Z-1244-2022",
      "event_date_initiated": "2022-04-06",
      "event_date_created": "2022-06-07",
      "recall_status": "Open, Classified",
      "res_event_number": "90060",
      "product_code": "CFF",
      "k_numbers": [
        "K111369"
      ],
      "product_description": "V8 Immunodisplacement Kit REF 1803",
      "code_info": "Model Number: 1803 UDI Codes: +M52518030/SS73-21-1803/14D20230831Z +M52518030/SS71-21-1803/14D20230830X Lot 3-21-1803 Lot 1-22-1803",
      "firm_fei_number": "1618982",
      "recalling_firm": "Helena Laboratories, Corp.",
      "address_1": "1530 Lindbergh Dr",
      "city": "Beaumont",
      "state": "TX",
      "postal_code": "77707-4131",
      "additional_info_contact": "Dr. Jessica Jones Hanka\n409-842-3714 Ext. 1177",
      "reason_for_recall": "Due to microbial growth causing interference with interpretation.",
      "root_cause_description": "Unknown/Undetermined by firm",
      "action": "On 04/06/2022, Helena Laboratories emailed an \"URGENT MEDICAL DEVICE RECALL\" Letter to customers informing them that the firm is recalling V8 Immunodisplacement Kit Lots 3-21-1803, and 1-22-1803 due to visible particulate contamination in some vials of a component within the kit - the IgG antisera.  Use of this product may result in an artifact anodal to albumin potentially interfering with interpretation of the IgG pattern.\n\nCustomers are instructed to immediately evaluate their inventory for product subject to recall, and quarantine accordingly.  All unused bottles in the field will be removed from the field, and replaced with an unaffected lot.\n\nFor questions or further assistance, email or call Dr. Jessica Jones Hanka at jhanka@helena.com or 1-800-231-5663 extension 1600.",
      "product_quantity": "51 kits",
      "distribution_pattern": "U.S.: FL, MO, OH, and TX\n\nO.U.S.: Canada, Uruguay, and Vietnam,",
      "openfda": {
        "k_number": [
          "K981048",
          "K033187",
          "K111369",
          "K192095",
          "K033277",
          "K203184",
          "K993213",
          "K120169",
          "K892424",
          "K993323",
          "K002799",
          "K061069",
          "K933972",
          "K161928",
          "K924769",
          "K923658",
          "K103757",
          "K190851",
          "K960669",
          "K172195",
          "K924767",
          "K823884",
          "K024162",
          "K082388",
          "K143483",
          "K973040",
          "K082085",
          "K990998",
          "K790667"
        ],
        "device_name": "Immunoelectrophoretic, Immunoglobulins, (G, A, M)",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5510",
        "device_class": "2",
        "registration_number": [
          "2084025",
          "1000403749",
          "3003961883",
          "3009736003",
          "8023024",
          "3019906",
          "1618982"
        ],
        "fei_number": [
          "2084025",
          "1000403749",
          "3003961883",
          "3009736003",
          "3019906",
          "6387",
          "1618982"
        ]
      }
    }
  ]
}