{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Parsippany",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "80826",
      "recalling_firm": "Diagnostica Stago, Inc.",
      "address_1": "5 Century Dr",
      "address_2": "N/A",
      "postal_code": "07054-4607",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "Z-2994-2018",
      "product_description": "Diagnostica Stago STA  N¿oplastine¿ CI, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma.  REF: 00666    The STA¿ - N¿oplastine¿ CI kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R¿, STA Compact¿ and STA Satellite¿. (In the USA this procedure has been assigned to the moderate complexity category per CLIA 1988 - CDC Analyte Code 4922; CDC Test System Codes 4677 and 4875).",
      "product_quantity": "5 kits",
      "reason_for_recall": "QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)",
      "recall_initiation_date": "20180724",
      "center_classification_date": "20180907",
      "termination_date": "20200518",
      "report_date": "20180919",
      "code_info": "Lot Number/Exp. Date/UDI  251426 2018-11-30   (01)03607450006667(11)161130(17)181130(10)251426(241)00666;  251763 2019-02-28   (01)03607450006667(11)170228(17)190228(10)251763(241)00666"
    }
  ]
}