{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 11
    }
  },
  "results": [
    {
      "cfres_id": "175957",
      "product_res_number": "Z-0045-2020",
      "event_date_initiated": "2017-07-21",
      "event_date_created": "2019-10-04",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-06-19",
      "res_event_number": "83622",
      "product_code": "CFF",
      "k_numbers": [
        "K973040"
      ],
      "product_description": "SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use.  The firm name on the label is Helena Laboratories, Beaumont, TX.",
      "code_info": "Lot 35-17-552583, exp. date 4/30/2018",
      "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": "The plates do not have wells punched for the controls in the patient 1 area.",
      "root_cause_description": "Employee error",
      "action": "The recall was initiated via phone on 7/21/2017 requesting the customer return the product for replacement if they routinely use the control wells.",
      "product_quantity": "24 kits",
      "distribution_pattern": "Distribution was made to IN, KY,  MA, OH, OR, TN, and TX.  There was government distribution.  Foreign distribution was made to Chile.",
      "openfda": {
        "k_number": [
          "K981048",
          "K143483",
          "K002799",
          "K082388",
          "K790667",
          "K933972",
          "K923658",
          "K203184",
          "K033187",
          "K993213",
          "K082085",
          "K924769",
          "K061069",
          "K823884",
          "K960669",
          "K993323",
          "K111369",
          "K172195",
          "K161928",
          "K192095",
          "K033277",
          "K120169",
          "K892424",
          "K103757",
          "K973040",
          "K924767",
          "K024162",
          "K190851",
          "K990998"
        ],
        "device_name": "Immunoelectrophoretic, Immunoglobulins, (G, A, M)",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5510",
        "device_class": "2",
        "registration_number": [
          "3003961883",
          "3019906",
          "2084025",
          "1000403749",
          "3009736003",
          "1618982",
          "8023024"
        ],
        "fei_number": [
          "3003961883",
          "3019906",
          "2084025",
          "1000403749",
          "6387",
          "3009736003",
          "1618982"
        ]
      }
    }
  ]
}