{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "178244",
      "product_res_number": "Z-0737-2020",
      "event_date_initiated": "2019-11-18",
      "event_date_posted": "2019-12-23",
      "recall_status": "Terminated",
      "event_date_terminated": "2023-01-12",
      "res_event_number": "84402",
      "product_code": "GIZ",
      "k_numbers": [
        "K922021"
      ],
      "product_description": "STA   UNICALIBRATOR (ref. 00675)",
      "code_info": "REF: 00675 Lot Numbers: 253180, 253964, 254721, 255108 UDIs: (01)13607450006756(11)171231(17)191231(10)253180(241)00675 (01)13607450006756(11)180630(17)200630(10)253964(241)00675 (01)13607450006756(11)181130(17)201130(10)254721(241)00675 (01)13607450006756(11)190228(17)210228(10)255108(241)00675",
      "firm_fei_number": "2245451",
      "recalling_firm": "Diagnostica Stago, Inc.",
      "address_1": "5 Century Dr",
      "city": "Parsippany",
      "state": "NJ",
      "postal_code": "07054-4607",
      "additional_info_contact": "973-631-1200",
      "reason_for_recall": "A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias is also observed on several External Quality Assessment (EQA) results.",
      "root_cause_description": "Process control",
      "action": "On November 18, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail stating:\nFIELD SAFETY NOTICE\nCombined use of the following reagents\nSTA   UNICALIBRATOR (ref. 00675)\nand\nSTA   DEFICIENT VIII (ref. 00725)\nSTA   DEFICIENT IX (ref. 00724)\n\nDear Customer,\nYou are using the STA   Unicalibrator (00675) and STA   Deficient VIII (00725) and/or STA   Deficient IX (00724) and according to our records, you have ordered and received in your laboratory one or several kits of the STA - Unicalibrator listed in Appendix 1.\n\nFollowing the identification of a defect, please see the information below about the reagents\nand lots listed in Appendix 1.\n\nDescription:\nFollowing a customer complaint, Stago has investigated and confirmed a positive bias on some STA - Unicalibrator levels. These high levels affect tests using STA - Deficient IX and STA - Deficient VIII reagents.\n\nStago has accordingly reduced the concerned Unicalibrator plasma levels (see new levels on the attached lot-specific barcode sheets).\n\nAccording to our internal testing results, the reduced Unicalibrator plasma levels result in a decrease of Factor VIII and IX results on normal and below-normal patient plasmas. This change has no impact on the classification of hemophiliac patients (type A or B) as severe, moderate or mild.\n\nThe reassignment of the Unicalibrator plasma levels necessitated a change in the acceptance ranges on the corresponding Quality Control plasmas for Factor VIII and IX parameters with the STA - Deficient VIII and IX reagents.\n\nYou will find new barcode sheets for each lot of the affected reagents in the attachments.\n\nActions:\nUpon receipt of this letter, we kindly ask you to:\n- No longer use the values indicated for STA - Deficient VIII and IX reagents on the barcode sheets in your possession (for the reagents & lots listed in Appendix 1).\n- Use the new barcode sheets (attached): \n     - For STA - Unicalibrator: Use the analyzer-spec",
      "product_quantity": "5,498",
      "distribution_pattern": "US: MA ME VT CT NJ NY PA DC MD VA NC SC GA FL AL TN MS KY OH IN MI IA WI MN SD ND MT IL MO KS LA AR OK TX CO AZ NV CA HI OR WA AK",
      "openfda": {
        "k_number": [
          "K880712",
          "K023309",
          "K973274",
          "K060968",
          "K961814",
          "K984129",
          "K013708",
          "K001256",
          "K891179",
          "K895262",
          "K003328",
          "K905203",
          "K893783",
          "K935254",
          "K042941",
          "K932145",
          "K893784",
          "K941737",
          "K924403",
          "K922021"
        ],
        "registration_number": [
          "1721937",
          "2431530",
          "3037000637",
          "1928890",
          "3014150341",
          "1618982",
          "3003691680",
          "9610806",
          "1000340866",
          "8043599",
          "3013660430",
          "1181121",
          "1835316",
          "9710666",
          "2245451"
        ],
        "fei_number": [
          "1000117401",
          "2431530",
          "3037000637",
          "1928890",
          "3001644026",
          "3014150341",
          "1618982",
          "3003691680",
          "1000340866",
          "3003565434",
          "3013660430",
          "1181121",
          "3005917516",
          "2245451",
          "3000210416"
        ],
        "device_name": "Plasma, Control, Normal",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.5425",
        "device_class": "2"
      }
    }
  ]
}