{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "30404",
      "product_res_number": "Z-0230-04",
      "event_date_initiated": "2003-11-13",
      "event_date_posted": "2003-12-17",
      "recall_status": "Terminated",
      "event_date_terminated": "2004-10-29",
      "res_event_number": "27717",
      "product_code": "MLM",
      "pma_numbers": [
        "P970007"
      ],
      "product_description": "IMx Tacrolimus II Assay, list 3C10-20; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064",
      "code_info": "All lot numbers",
      "firm_fei_number": "1415939",
      "recalling_firm": "Abbott Laboratories HPD/ADD/GPRD",
      "address_1": "100/200 Abbott Park Road",
      "city": "Abbott Park",
      "state": "IL",
      "postal_code": "60064",
      "additional_info_contact": "Abbott Customer Support\n877-422-2688",
      "reason_for_recall": "Inadequate instructions for use resulting in calibration errors and the protein interference data in the package insert is not representative of assay performances.",
      "root_cause_description": "Other",
      "action": "Device correction recall initiated by letters dated 11/12/03.  Letters were sent to all current IMx Tacrolimus II customers worldwide, advising them that calibration errors and controls out of range be the result of variance with the sample pretreatment steps listed in the package insert, and that the protein interference data in the insert is not representative of assay performance (12% when it should state less than 22% error) .  A Customer Training Guide was included in the letter, outlining steps to aid the assay user in performing the pretreatment step and listing the most common deviations that can impact results.",
      "product_quantity": "not lot specific",
      "distribution_pattern": "Nationwide and internationally to Guatemala, Venezuela, Columbia, Peru, Chile, Australia, Panama, Argentina, Puerto Rico, Dominican Republic, Canada, Germany, New Zealand, England, Japan, Singapore, Thailand, Korea and Costa Rica.",
      "openfda": {
        "k_number": [
          "K063868",
          "K123343",
          "K203833",
          "K070820",
          "K050206",
          "K060502",
          "K150168",
          "K060385",
          "K173857"
        ],
        "pma_number": [
          "P970007",
          "P970025"
        ],
        "registration_number": [
          "9610126",
          "3005333358",
          "3026848661",
          "1643621",
          "2521625",
          "2432235",
          "1218959",
          "3003951180",
          "2517506",
          "9616673",
          "1415939",
          "3008344661",
          "3010939897"
        ],
        "fei_number": [
          "1643621",
          "3005333358",
          "3026848661",
          "2521625",
          "2432235",
          "1218959",
          "3003179344",
          "3003951180",
          "2517506",
          "1415939",
          "3008344661",
          "3010939897",
          "3002806559"
        ],
        "device_name": "Enzyme Immunoassay, Tracrolimus",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1678",
        "device_class": "2"
      }
    }
  ]
}