{
  "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,
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    }
  },
  "results": [
    {
      "cfres_id": "38380",
      "product_res_number": "Z-0784-05",
      "event_date_initiated": "2005-03-16",
      "event_date_posted": "2005-04-28",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-07-22",
      "res_event_number": "31710",
      "product_code": "LIP",
      "k_numbers": [
        "K001552"
      ],
      "product_description": "Trep-Chek Syphilis Test Kit, 960 tests, Catalog No. TP-960, Distributed by DiaSorin,  Inc. 1951 Northwestern Ave, Stillwater, MN  55082-0285 USA.   Manufactured by Phoenix Bio-Tech Corp., 6910 Kitimat Road, Unit #1, Mississauga, Ontario, Canada L5N 5M2.",
      "code_info": "lot # 041207T  expiration date 9-30-2005",
      "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": "Package insert incorrectly states that specimen diluent is ready to use, however specimen diluent bottle in kit states that the diluent must be diluted to one liter.",
      "root_cause_description": "Other",
      "action": "Customers were contacted via telephone, informed of the incorrect package insert, asked to destroy any incorrect inserts and  a correct insert was faxed to customers.",
      "product_quantity": "14 kits",
      "distribution_pattern": "MA, CA, TX, KS, NY, FL",
      "openfda": {
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        "device_name": "Enzyme Linked Immunoabsorption Assay, Treponema Pallidum",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3830",
        "device_class": "2"
      }
    }
  ]
}