{
  "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": "83629",
      "recalling_firm": "Helena Laboratories, Corp.",
      "address_1": "1530 Lindbergh Dr",
      "address_2": "N/A",
      "postal_code": "77707-4131",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distribution was made to Germany and Australia.  There was no U.S. distribution.",
      "recall_number": "Z-2761-2019",
      "product_description": "Cascade Abrazo aPTT Test Card, Model 5722, For Export Only.  The firm name on the label is Helena Laboratories, Beaumont, TX.",
      "product_quantity": "21 kits",
      "reason_for_recall": "Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay.",
      "recall_initiation_date": "20171207",
      "center_classification_date": "20190930",
      "termination_date": "20200609",
      "report_date": "20191009",
      "code_info": "Lot number 2-17-5722, Exp. 2018-09-30"
    }
  ]
}