{
  "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": [
    {
      "status": "Terminated",
      "city": "Beaumont",
      "state": "TX",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "81356",
      "recalling_firm": "Helena Laboratories, Inc.",
      "address_1": "1530 Lindbergh Dr",
      "address_2": "N/A",
      "postal_code": "77707-4131",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Distribution to state of TX and internationally to:  Australia, Netherlands, Italy, and England.",
      "recall_number": "Z-0594-2019",
      "product_description": "Cascade Abrazo c-ACT-LR Test Card  IVD FOR IN VITRO DIAGNOSTIC USE  Store at 2 to 8 C  HELENA LABORATORIES  003366  12/13(2)    FOR EXPORT ONLY    The Cascade Abrazo c-ACT-LR test cards are activated clotting time tests to be used with the Cascade Abrazo analyzer and are intended to monitor the effect of low to moderate heparin on coagulation in fresh whole blood.",
      "product_quantity": "12 Kits",
      "reason_for_recall": "Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected",
      "recall_initiation_date": "20160420",
      "center_classification_date": "20181210",
      "termination_date": "20240215",
      "report_date": "20181219",
      "code_info": "Lot Codes: 1-15-5701  Model/Catalog Number: 5701"
    }
  ]
}