{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "cfres_id": "158557",
      "product_res_number": "Z-0002-2018",
      "event_date_initiated": "2017-08-23",
      "event_date_created": "2017-10-04",
      "recall_status": "Terminated",
      "event_date_terminated": "2019-02-21",
      "res_event_number": "78047",
      "product_code": "DEM",
      "k_numbers": [
        "K123256"
      ],
      "product_description": "Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S.  The firm name on the label is The Binding Site Group Ltd., Birmingham, UK.\n\nProduct is designed for the quantitative in-vitro determination of Alpha-1-antitrypsin in human serum using the SPAPLUS turbidimetric analyser. The measurement of Alpha-1-antitrypsin aids in the diagnosis of several conditions including adult cirrhosis of the liver. In addition, Alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema. This test should be used in conjunction with other laboratory and clinical findings.",
      "code_info": "Lot #400900, Exp. 12/31/2017, UDI #05051700016421",
      "firm_fei_number": "3002808340",
      "recalling_firm": "The Binding Site Group, Ltd.",
      "address_1": "8 Calthorpe Road",
      "city": "Birmingham",
      "country": "United Kingdom",
      "additional_info_contact": "858-453-9177",
      "reason_for_recall": "The high control for the kit is recovering low and may be out of range for assigned values.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Binding Site sent an Field Safety Notice dated August 24, 2017, explaining the reason for recall and requesting the direct account and their customer to remove the affected kits from inventory and dispose of them.  The direct account  and their customers were instructed to circulate the field safety notice to other persons who use the product within their organization.   A response form, to be returned via email,  was enclosed for completion to indicate the number of kits discarded. For further questions, please call (858) 453-9177.",
      "product_quantity": "361 kits",
      "distribution_pattern": "Worldwide Distribution - US Distribution to the state of CA., and to the countries of : United Kingdom, Germany, France, Czech Republic, Belgium, Panama, Bulgaria, Iran, Argentina, Turkey Romania, Colombia, and Saudi Arabia.",
      "openfda": {
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          "K053072",
          "K850587",
          "K973390",
          "K791605",
          "K993444",
          "K031857",
          "K123256",
          "K050596",
          "K772080",
          "K760916",
          "K875283",
          "K052819",
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        "registration_number": [
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          "3004493545",
          "3019906",
          "3012963943",
          "9614373",
          "1319681",
          "9680746",
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        "fei_number": [
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        ],
        "device_name": "Alpha-1-Antitrypsin, Antigen, Antiserum, Control",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5130",
        "device_class": "2"
      }
    }
  ]
}