{
  "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": "85167",
      "recalling_firm": "Diagnostica Stago, Inc.",
      "address_1": "5 Century Dr",
      "address_2": "",
      "postal_code": "07054-4607",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Nationwide",
      "recall_number": "Z-1699-2020",
      "product_description": "STA - Deficient VIII, Product Code: 00725.  STA - Deficient VIII is an immuno-depleted human plasma intended for use in tests for the determination of factor VIII activity in plasma on STA-R and STA Compact analyzer platforms as follows:  (A) STA-R Max, Product Codes: 58989, 58990  (B) STA-R Evolution, Product Codes: 58986, 58987, 58988  (C) STA Compact Max, Product Codes: 59026, 59027  (D) STA Compact, Product Codes: 58978, 58979",
      "product_quantity": "3,225 units",
      "reason_for_recall": "A risk of sample-to-sample cross-contamination of Emicizumab for factor VIII assays on Stago instruments,  clotting times will be shortened that may cause factor VIII levels reported to be falsely increased",
      "recall_initiation_date": "20200304",
      "center_classification_date": "20200410",
      "termination_date": "20211110",
      "report_date": "20200422",
      "code_info": "All lots    This cleaning sequence has been implemented in the following available software versions.  Customers not possessing these software levels will be upgraded by Stago Field Support personnel:      STA-R¿ Max (all serial numbers):    Software version 4.05.04 or higher, and         Methodology Update (MU) to enhance database version MS215.     STA-R¿ Evolution (serial numbers higher than 8012756):   Software version 3.04.09 or higher   STA¿ Compact Max (all serial numbers):    Software version 110.05 or higher.",
      "more_code_info": ""
    }
  ]
}