{
  "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": {
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      "cfres_id": "104362",
      "product_res_number": "Z-0189-2012",
      "event_date_initiated": "2011-10-03",
      "event_date_posted": "2011-11-16",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-05-11",
      "res_event_number": "60059",
      "product_code": "CDQ",
      "k_numbers": [
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      "product_description": "Clinical Chemistry Urea Nitrogen List Number 7D75-21 and 7D75-31 used for the Quantitation of urea nitrogen in human serum, plasma, and urine.",
      "code_info": "Urea Nitrogen 7D75-21 (lot 97642UN11) and Urea Nitrogen 7D75-31 (lot 97668UN11)",
      "firm_fei_number": "1628664",
      "recalling_firm": "Abbott Laboratories, Inc",
      "address_1": "1921 Hurd Drive",
      "address_2": "PO Box 152020",
      "city": "Irving",
      "state": "TX",
      "postal_code": "75038-4313",
      "additional_info_contact": "Mark Littlefield\n972-518-6000",
      "reason_for_recall": "The reagents are being recalled due to particulate matter in some of the reagent cartridges.  The particulate matter has been identified as Aureobasidium fungus species.",
      "root_cause_description": "Process control",
      "action": "The firm decided to recall and they sent a Product Recall Letter to their customers on 10/03/2011.  Questions regarding the letter should be directed to Customer Service at 1-877-4ABBOTT for US customers, and customers outside of the US should contact their local area Customer Service. Customers should determine if you have any remaining inventory. Please discontinue and destroy any remaining inventory of these lots. Order alternative lots of Clinical Chemistry Urea Nitrogen. Complete and return the enclosed Customer Reply form.",
      "product_quantity": "5704 units of Urea Nitrogen",
      "distribution_pattern": "Worldwide Distribution.",
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        "device_name": "Urease And Glutamic Dehydrogenase, Urea Nitrogen",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1770",
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}