{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Grove City",
      "address_1": "3600 Gantz Rd",
      "reason_for_recall": "The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.",
      "address_2": "",
      "product_quantity": "6049",
      "code_info": "All lots.",
      "center_classification_date": "20180514",
      "distribution_pattern": "USA (nationwide) Distribution including PR and to the states of :  AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.",
      "state": "OH",
      "product_description": "Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218    The device is designed for In Vitro Diagnostic Use Only for the quantitative measurement for percent concentration of Hemoglobin A1c (HbA1c) in EDTA whole blood on Tosoh AIA System Analyzer. HbA1c measurement is used in the management and treatment of diabetes.",
      "report_date": "20180523",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Tosoh Bioscience Inc",
      "recall_number": "Z-1809-2018",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "79708",
      "termination_date": "20200616",
      "more_code_info": "",
      "recall_initiation_date": "20180305",
      "postal_code": "43123-1895",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}