{
  "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": "2258",
      "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 Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718    The device is intended for In Vitro Diagnostic Use Only for the pretreatment of the patient samples or control set for the HbA1c assay",
      "report_date": "20180523",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Tosoh Bioscience Inc",
      "recall_number": "Z-1812-2018",
      "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"
    }
  ]
}