{
  "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,
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  },
  "results": [
    {
      "cfres_id": "38420",
      "product_res_number": "Z-0776-05",
      "event_date_initiated": "2005-04-08",
      "event_date_posted": "2005-04-27",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-07-22",
      "res_event_number": "31735",
      "product_code": "LOL",
      "pma_numbers": [
        "P890014"
      ],
      "product_description": "DiaSorin ETI-HA-IGMK PLUS Enzyme Immunoassay for the Detection of IgM Antibody to Hepatitiis A Virus (IgM anti-HAV) in Human Serum or Plasma    Catalog No. P001925.  Manufactured by:  DiaSorin S.p.A. Saluggia, Italy",
      "code_info": "9850180E (expiration 08/02/2005);   9850180E/1 (expiration 08/02/2005);   9850180F (expiration 08/02/2005) and 9850190A (expiration 01/18/2006)",
      "firm_fei_number": "2182595",
      "recalling_firm": "Diasorin Inc.",
      "address_1": "1951 Northwestern Ave S",
      "city": "Stillwater",
      "state": "MN",
      "postal_code": "55082-7536",
      "reason_for_recall": "The package insert for Hepatitis A Virus IgM antibody kit (ETI-IgMK Plus, catalog P001925), may inadvertently contain pages 5 through 12 from the instructions for Hepatitus A virus Total antibody test (ETI-AB-HAVK Plus, catalog P001926).",
      "root_cause_description": "Other",
      "action": "Customers notified via mail, fax or email beginning 04/08/05 with a DiaSorin Customer Notification Letter which also contained a copy of the correct package insert.  Distributors were directed to forward copies of the recall letter and correct package insert to their customers.  Customers are instructed to destroy the incorrect insert.",
      "product_quantity": "2104",
      "distribution_pattern": "Nationwide including:  AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, WV and Puerto Rico",
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          "P790019",
          "P040017",
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        "fei_number": [
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        ],
        "device_name": "Hepatitis A Test (Antibody And Igm Antibody)",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3310",
        "device_class": "2"
      }
    }
  ]
}