{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "41355",
      "product_res_number": "Z-0557-06",
      "event_date_initiated": "2005-08-08",
      "event_date_posted": "2006-02-23",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-07-22",
      "res_event_number": "33128",
      "product_code": "LJY",
      "k_numbers": [
        "K991274"
      ],
      "product_description": "The ETI-Mumps IgG Enzyme Immunoassay Test Kit is sold with assay software version 1.0. that is designed to work exclusively with the ETI-Max 3000 automated platform (version 1.51.1).",
      "code_info": "ETI-Mumps Assay software version 1.0",
      "firm_fei_number": "2182595",
      "recalling_firm": "Diasorin Inc.",
      "address_1": "1951 Northwestern Ave S",
      "city": "Stillwater",
      "state": "MN",
      "postal_code": "55082-7536",
      "additional_info_contact": "Mary VanTassell\n651-439-9710",
      "reason_for_recall": "Potential for false negative results.\nA software anomaly may occur when performing the ETI-Mumps IgG assay on the ETI-Max 3000 automated platform.  The error occurs when running a combined plate on the ETI-Max 3000, with the ETI-Mumps IgG assay as the second assay on a combined plate with ETI-Measles IgG and/or ETI-VZV IgG.",
      "root_cause_description": "Other",
      "action": "Consignees were contacted by telephone and then the firm sent a fax titled 'Diasorin Customer Notification' dated 8/8/05 that documented the information as provided by telephone.",
      "product_quantity": "22",
      "distribution_pattern": "Nationwide.  AK, CA, CT, DC, KS, MA, NY, NJ, PA, SD, TN, TX.",
      "openfda": {
        "k_number": [
          "K971857",
          "K980059",
          "K991274",
          "K961204",
          "K897006",
          "K830045",
          "K925209",
          "K923903"
        ],
        "registration_number": [
          "9615056",
          "8020790",
          "3013718871",
          "3032705",
          "3005542422",
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          "3007208259",
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        ],
        "fei_number": [
          "3002701146",
          "1000611339",
          "3013718871",
          "3005542422",
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          "2915274",
          "3002800697",
          "1641328",
          "3006759904",
          "1000306617"
        ],
        "device_name": "Enzyme Linked Immunoabsorbent Assay, Mumps Virus",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3380",
        "device_class": "1"
      }
    }
  ]
}