{
  "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-2993-2018",
      "product_description": "Diagnostica Stago STA   N¿oplastine¿ CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma.  (REF 00667)    The STA¿ - N¿oplastine¿ CI Plus 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": "24043 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  250791 2018-07-31   (01)03607450006674(11)160731(17)180731(10)250791(241)00667;  250792 2018-07-31  (01)03607450006674(11)160731(17)180731(10)250792(241)00667;  250911 2018-08-31  (01)03607450006674(11)160831(17)180831(10)250911(241)00667;  251231 2018-10-31   (01)03607450006674(11)161031(17)181031(10)251231(241)00667;  251311 2018-11-30  (01)03607450006674(11)161130(17)181130(10)251311(241)00667;  251364 2018-11-30  (01)03607450006674(11)161130(17)181130(10)251364(241)00667;  251427 2018-11-30   (01)03607450006674(11)161130(17)181130(10)251427(241)00667;  251528 2018-12-31   (01)03607450006674(11)161231(17)181231(10)251528(241)00667;  251707 2019-01-31   (01)03607450006674(11)170131(17)190131(10)251707(241)00667;  251708 2019-01-31   (01)03607450006674(11)170131(17)190131(10)251708(241)00667;  251767 2019-02-28   (01)03607450006674(11)170228(17)190228(10)251767(241)00667;  251800 2019-02-28   (01)03607450006674(11)170228(17)190228(10)251800(241)00667;  252534 2019-07-31   (01)03607450006674(11)170731(17)190731(10)252534(241)00667;  252737 2019-09-30   (01)03607450006674(11)170930(17)190930(10)252737(241)00667"
    }
  ]
}