{
  "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": {
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    {
      "cfres_id": "105523",
      "product_res_number": "Z-0512-2012",
      "event_date_initiated": "2011-10-14",
      "event_date_posted": "2012-01-11",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-04-09",
      "res_event_number": "60476",
      "product_code": "KQO",
      "product_description": "Urine Reagent Strips (URS) 11 Parameters\nURS-11-100G-001\n\n510(K) number: K970250\nDevise Listing number: D072377\n\nEach Device consists of 100 strips of Urine Reagent Strips 11 parameters packed with a desiccant pouch inside a black bottle with Cortez Diagnostics Label on the bottle and the bottle placed inside a Cortez Diagnostics Box.",
      "code_info": "Product # 2:  URS-II-I00G-00I i. Lot Number: 35224 ii. Expiration Date: 08/2013",
      "firm_fei_number": "1832216",
      "recalling_firm": "Teco Diagnostics",
      "address_1": "1268 N Lakeview Ave",
      "city": "Anaheim",
      "state": "CA",
      "postal_code": "92807-1831",
      "additional_info_contact": "Ms. Jenifer Ohta\n714-463-1111",
      "reason_for_recall": "This recall was initiated in response to findings during a FDA inspection of the firm.  The firm's recall has been initiated due to improper manufacture of sub-component nitrite paper Lot 35134, Expiration Date: 01/2014. Discrepancies were found on the information recorded on formulation sheet and manufacturing log sheets. Sampling size submitted for QC testing was insufficient based upon number o",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Teco Diagnostics sent an \"URGENT: MEDICAL DEVICE RECALL\" letter dated October 14, 2011 to affected customers.  The letter described the product, problem, and actions to be taken by the customers.  The letter instructed customers to examine their inventory for the affected product and to quarantine  any product found.  A Recall Return Response Form was included with the letter for customers to complete and return.  Contact the firm's Technical Support Department at  (800) 222-9880 for questions regarding this recall.",
      "distribution_pattern": "Distributed in CA and Poland.",
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        "device_name": "Automated Urinalysis System",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.2900",
        "device_class": "1"
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}