{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Grove City",
      "address_1": "3600 Gantz Rd",
      "reason_for_recall": "Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the calibration unacceptable.",
      "address_2": "",
      "product_quantity": "34 boxess/2 sets/6 bottles",
      "code_info": "Part Number 020391; Lot # B834868, Lot # BX34869, Lot # C234871, Lot # C434872 & Lot # C534873.",
      "center_classification_date": "20210308",
      "distribution_pattern": "US Nationwide distribution in the states of CA, FL, GA, NY, OH & OR.",
      "state": "OH",
      "product_description": "Thyroglobulin Antibody (TgAB) Calibrator - Product Usage:  intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of anti-thyroglobulin antibodies (TgAb) in human serum on specific TOSOH AIA System analyzers. Measurements obtained by this device aid in the diagnosis of autoimmune thyroid disorders, such as Graves\u0019 disease and Hashimoto\u0019s disease. Comment to IU: Please note that the Calibrator set is not part of the IU but required for the assay.",
      "report_date": "20210317",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Tosoh Bioscience Inc",
      "recall_number": "Z-1187-2021",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "76372",
      "termination_date": "20210708",
      "more_code_info": "",
      "recall_initiation_date": "20120223",
      "postal_code": "43123-1895",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}