{
  "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": "2026-08-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "West Chester",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "99344",
      "recalling_firm": "Aniara Diagnostica LLC",
      "address_1": "7768 Service Center Dr",
      "address_2": "",
      "postal_code": "45069-2442",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution in the states of IL, NC, TN.",
      "recall_number": "Z-2895-2026",
      "product_description": "5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905",
      "product_quantity": "7 units",
      "reason_for_recall": "Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.",
      "recall_initiation_date": "20260701",
      "center_classification_date": "20260805",
      "report_date": "20260812",
      "code_info": "UDI-DI: 05070002420392, Lot Number: KE132601",
      "more_code_info": ""
    }
  ]
}