{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Boston",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "90323",
      "recalling_firm": "Haemonetics Corporation",
      "address_1": "125 Summer St",
      "address_2": "",
      "postal_code": "02110-1616",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "",
      "distribution_pattern": "Domestic distribution US Nationwide.",
      "recall_number": "Z-1310-2022",
      "product_description": "TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034",
      "product_quantity": "3933 kits (US); 2429 kits (OUS)",
      "reason_for_recall": "Due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU are changing. If the clinician relies solely on affected results in comparison to the normal donor reference range, it could lead to misdiagnosis and incorrect treatment or failure to treat.",
      "recall_initiation_date": "20220426",
      "center_classification_date": "20220630",
      "termination_date": "20240315",
      "report_date": "20220706",
      "code_info": "UDI-DI: (01)20812747018095    All lots are affected.",
      "more_code_info": ""
    }
  ]
}