{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "36821",
      "product_res_number": "Z-0702-05",
      "event_date_initiated": "2004-04-12",
      "event_date_posted": "2005-04-13",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-07-22",
      "res_event_number": "30929",
      "product_code": "MLM",
      "pma_numbers": [
        "P970025"
      ],
      "product_description": "Version 12 software program written for the Bio-Tek ELx800 automated microtiter plate reader with use of PRO-Trac Tacrolimus ELISA kit",
      "code_info": "version 12",
      "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": "DiaSorin Technical Services\n800-328-1482",
      "reason_for_recall": "The software program written for use in the automated microtiter plate reader (Bio-Tek ELx800) for use with the Pro-Trac II Tacrolimus ELISA kit was found to be faulty.  Assay software program did not include the Calibrator Zero OD specification (STDO>=1.500) as specified in the product insert.",
      "root_cause_description": "Other",
      "action": "Customers were sent notification letters and effectiveness check form. recommended users manually veify results using product insert specifications.",
      "distribution_pattern": "CA, Washington DC, FL, KY  & Canada",
      "openfda": {
        "k_number": [
          "K060502",
          "K150168",
          "K173857",
          "K060385",
          "K203833",
          "K123343",
          "K050206",
          "K063868",
          "K070820"
        ],
        "pma_number": [
          "P970007",
          "P970025"
        ],
        "registration_number": [
          "1643621",
          "2432235",
          "3005333358",
          "3008344661",
          "1218959",
          "1415939",
          "9616673",
          "2517506",
          "9610126",
          "3026848661",
          "2521625",
          "3010939897",
          "3003951180"
        ],
        "fei_number": [
          "1643621",
          "2432235",
          "3005333358",
          "3008344661",
          "1415939",
          "1218959",
          "3002806559",
          "2517506",
          "3003179344",
          "3026848661",
          "2521625",
          "3010939897",
          "3003951180"
        ],
        "device_name": "Enzyme Immunoassay, Tracrolimus",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1678",
        "device_class": "2"
      }
    }
  ]
}