{
  "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": "Canton",
      "address_1": "5449 Research Dr",
      "reason_for_recall": "A Discrepancy was found on Hitachi AST (HA7 61) package insert.  Limitations section indicates linearity is 500 U/L and the Performance  section linearity is listed as 0-600 U/L, which is not consistent with the  510k submission package insert.",
      "address_2": "",
      "product_quantity": "119.168L across All lots",
      "code_info": "Catalog numbers: HA461, HA761 , HA961 and lot codes:022204, 034801, 102401, 119503, and 134101.",
      "center_classification_date": "20170518",
      "distribution_pattern": "US Nationwide Distribution",
      "state": "MI",
      "product_description": "Pointe Scientific Hitachi AST Reagent    R1 : PE plastic bottle w/PP plastic cap.  R2: PE plastic bottle w /PP plastic cap.    Product Usage:  Two Part Chemistry Reagent For the quantitative determination of Aspartate Aminotransferase (ASl) in human serum on Hitachi analyzers.",
      "report_date": "20170524",
      "classification": "Class III",
      "openfda": {},
      "recalling_firm": "Medtest Holdings, Inc.",
      "recall_number": "Z-2116-2017",
      "initial_firm_notification": "E-Mail",
      "product_type": "Devices",
      "event_id": "76985",
      "termination_date": "20170602",
      "more_code_info": "",
      "recall_initiation_date": "20120215",
      "postal_code": "48188-2261",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}