{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "29762",
      "product_res_number": "Z-0063-04",
      "event_date_initiated": "2003-09-19",
      "event_date_posted": "2003-10-24",
      "recall_status": "Terminated",
      "event_date_terminated": "2004-10-29",
      "res_event_number": "27374",
      "product_code": "MLM--",
      "pma_numbers": [
        "P970007"
      ],
      "product_description": "IMx Tacrolimus II Calibrators, list 3C10-10; the pack contains six 4.5-mL bottles, with Calibrator A having 0 ng/mL, Calibrator B having 3 ng/mL, Calibrator C having 6 ng/mL, Calibrator D having 12 ng/mL, Calibrator E having 20 ng/mL and Calibrator F having 30 U/mL; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064",
      "code_info": "list 3C10-10, lots 94165M100 and 94164M100",
      "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": "Invalid test results are being generated due to calibration errors when using calibrator lots 94165M100 and 94164M100.",
      "root_cause_description": "Other",
      "action": "Recalled by letters dated 9/19/03 and 10/7/03. The accounts were informed of the inability to calibrate the IMx Tacrolimus II assay when using calibrator lots 94165M100 and 94164M100, and initially requested those accounts experiencing an increase in calibration-related errors to report the issue to Abbott for a replacement calibrator kit.  The 10/7/03 letter requested the accounts to discontinue use and destroy any of the two affected calibrator lots found in inventory.",
      "product_quantity": "2677 kits",
      "distribution_pattern": "Nationwide and internationally to Guatemala, Venezuela, Peru, Argentina, Dominican Republic, Canada, Japan, Singapore, Thailand, Korea, Australia, Costa Rica, Panama and Great Britain.",
      "openfda": {}
    }
  ]
}