{
  "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": "2026-05-06",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "San Diego",
      "address_1": "3030 Bunker Hill St Ste 115a",
      "reason_for_recall": "The recall was initiated because Critical Diagnostics has confirmed that it is possible to obtain inaccurate test results for specimens when using the Presage ST2 Assay kits.",
      "address_2": "",
      "product_quantity": "33 units",
      "code_info": "BC-1065 (US distribution) Lot No. RN-43116-4  BC-1065 E (European Distribution) Lot No. RN-42467-1, RN-42467-2, RN-43116-1, RN-43116-2, RN-43116-3.",
      "center_classification_date": "20120713",
      "distribution_pattern": "USA including the state of California  and the countries of  Austria, Spain, United Kingdom, and Italy.",
      "state": "CA",
      "product_description": "Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E.    The Critical Diagnostics Presage ST2 Assay kit is an in vitro diagnostic device that quantitatively measures ST2 in serum or plasma by enzyme-linked immunosorbent assay (ELISA) in a microtiter plate format. The Presage ST2 Assay is indicated to be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.",
      "report_date": "20120725",
      "classification": "Class III",
      "openfda": {},
      "recalling_firm": "Critical Diagnostics",
      "recall_number": "Z-2012-2012",
      "initial_firm_notification": "E-Mail",
      "product_type": "Devices",
      "event_id": "62281",
      "termination_date": "20120716",
      "more_code_info": "",
      "recall_initiation_date": "20120228",
      "postal_code": "92109-5754",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}