{
  "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": "205347",
      "product_res_number": "Z-0815-2024",
      "event_date_initiated": "2023-12-13",
      "event_date_posted": "2024-01-25",
      "recall_status": "Open, Classified",
      "res_event_number": "93741",
      "product_code": "MYF",
      "k_numbers": [
        "K081687"
      ],
      "product_description": "DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620",
      "code_info": "UDI/DI 08056771600101, Lot Numbers:  136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C, 136775",
      "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": "651-439-9710",
      "reason_for_recall": "DiaSorin has identified that lots 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C\n136775of LIAISON HSV-2 Type Specific IgG assay may produce increased equivocal and/or false positive results.",
      "root_cause_description": "Under Investigation by firm",
      "action": "DiaSorin issued a DIASORIN CUSTOMER NOTIFICATION LETTER to its consignees on 12/13/2023 via email.  The notice explained the issue, risk to health, and requested the disposal of all affected inventory.  The firm will be providing replacement kits.",
      "product_quantity": "31992 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the country of Canada.",
      "openfda": {
        "k_number": [
          "K103603",
          "K033106",
          "K181334",
          "K061239",
          "K181514",
          "K993724",
          "K081687",
          "K220924",
          "K243575",
          "K152353"
        ],
        "registration_number": [
          "3032705",
          "9610746",
          "1318354",
          "9610126",
          "2915274",
          "2242436",
          "2023365",
          "3008344661",
          "2029372",
          "1641328",
          "2182595",
          "3005333358",
          "2432235"
        ],
        "fei_number": [
          "3002701146",
          "1318354",
          "2915274",
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          "2023365",
          "3002806557",
          "3008344661",
          "1641328",
          "2182595",
          "3005333358",
          "3002806559",
          "1000306617",
          "2432235"
        ],
        "device_name": "Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3305",
        "device_class": "2"
      }
    }
  ]
}