{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "126910",
      "product_res_number": "Z-0179-2015",
      "event_date_initiated": "2014-04-18",
      "event_date_posted": "2014-11-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-08-14",
      "res_event_number": "68079",
      "product_code": "NJT",
      "product_description": "Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in Tris buffered saline with carrier protein, containing 0.35% ProClin 950 as a preservative. Total volume = 7 mL.\r\n\r\nThis reagent is for in vitro diagnostic use. Thyroglobulin (1D4) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of thyroglobulin in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using an automated Bond system. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.",
      "code_info": "Product Code: PA0025; Lot Numbers and Expiration Dates: 24963, Expires 17 DEC 2014; 24228, Expires 15 OCT 2014; 23882, Expires 10 SEP 2014; 23366, Expires 23 JUL 2014",
      "firm_fei_number": "3000210133",
      "recalling_firm": "Leica Microsystems, Inc.",
      "address_1": "1700 Leider Ln",
      "city": "Buffalo Grove",
      "state": "IL",
      "postal_code": "60089-6622",
      "additional_info_contact": "847-405-5413",
      "reason_for_recall": "Bond Ready to Use Primary Antibody Thyroglobulin does not function as intended up to the expiry date on the product labelling. This was detected through an on-going stability program. There is a link between the age of the product and staining intensity.",
      "root_cause_description": "Unknown/Undetermined by firm",
      "action": "Leica Biosystems sent a Medical Device Recall Notification letter  dated April 18, 2014, to all affected customers.  The letter included instructions for customers to: 1) assess any results previously obtained by using the recalled products; 2) identify and destroy any unused or partly used recalled products or confirm that the recalled products are no longer in stock; and, 3) complete and return the attached Medical Device Recall Notification Acknowledgement Form. Customers with questions were instructed to contact Leica Microsystems by e-mail at LMGRA@leica-microsystems.com.\r\nFor questions regarding this recall call 847-405-5413.",
      "product_quantity": "180 units",
      "distribution_pattern": "Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, MT, MY, NC, NH, NJ, NY, OH, ON, OR, PA, TN, TX, UT, VA, WA, WI and the District of Columbia,  Internationally to  Belgium, Bulgaria, France, Italy, Pakistan, Philippines, Russia, Saudi Arabia, Spain, Turkey, and the United Kingdom.",
      "openfda": {
        "registration_number": [
          "3009963993",
          "2022180",
          "3014429566",
          "3017212430",
          "3007035884",
          "9610099",
          "3013059683",
          "3008776165",
          "9610529",
          "3015258926",
          "3027582128",
          "3010939897",
          "3017170972",
          "1640981",
          "3008505743",
          "3003741796",
          "3004140393",
          "3003335080",
          "3005592623",
          "1649339",
          "8020030",
          "2914537",
          "3017439370",
          "9610126",
          "3003423869",
          "3017379203",
          "3010890428",
          "3042159574",
          "3042585783",
          "3004859032",
          "3010139432",
          "3009189893",
          "3008773547",
          "3014165737",
          "2028492",
          "3015614371",
          "1831638",
          "3016764932",
          "3004074729",
          "3012214605",
          "2916205",
          "3030509363",
          "3013043616",
          "2083544",
          "3008174888"
        ],
        "fei_number": [
          "3009963993",
          "2022180",
          "3000718726",
          "3014429566",
          "3017212430",
          "1000125183",
          "3006461677",
          "3007035884",
          "3013059683",
          "3015258926",
          "3027582128",
          "3010939897",
          "3017170972",
          "1640981",
          "3008505743",
          "3003741796",
          "3004140393",
          "3003335080",
          "3005592623",
          "2914537",
          "3017439370",
          "3003423869",
          "3017379203",
          "3010890428",
          "3042159574",
          "3042585783",
          "2936532",
          "3004859032",
          "3010139432",
          "3009189893",
          "3008773547",
          "2083544",
          "3002806560",
          "3014165737",
          "3015614371",
          "1831638",
          "3016764932",
          "3002806778",
          "3012214605",
          "3004074729",
          "2916205",
          "3030509363",
          "3013043616",
          "3002806559",
          "3008174888"
        ],
        "device_name": "Immunohistochemistry Reagents And Kits",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.1860",
        "device_class": "1"
      }
    }
  ]
}