{
  "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": "53649",
      "product_res_number": "Z-0003-2008",
      "event_date_initiated": "2007-05-02",
      "event_date_posted": "2007-10-04",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-11-26",
      "res_event_number": "38430",
      "product_code": "MSQ",
      "k_numbers": [
        "K014225"
      ],
      "product_description": "BreathTek Urea Hydrolysis Rate Calculation CD, Version 1.3.5 - January 1,'03, in vitro diagnostic. Meretek Diagnostics, Inc., Lafayette, CO.",
      "code_info": "Version 1.3.5 - January 1, '03",
      "firm_fei_number": "3000210499",
      "recalling_firm": "Meretek Diagnostics, Inc.",
      "address_1": "2655 Crescent Drive, Suite C 2655 Crescent Drive",
      "address_2": "Suite C",
      "city": "Lafayette",
      "state": "CO",
      "postal_code": "80026",
      "additional_info_contact": "Juli Marki\n720-479-6409",
      "reason_for_recall": "Diagnostic test kit for Helicobacter pylori was distributed for adult and pediatric use, but was not approved for pediatric use.",
      "root_cause_description": "Labeling False and Misleading",
      "action": "Customers were notified by letter on 05/02/2007 and asked to remove the software program from any computers on which it had been installed and return the software disc and User's Guide to Meretek.",
      "product_quantity": "92 units",
      "distribution_pattern": "Nationwide.",
      "openfda": {
        "k_number": [
          "K014225",
          "K220494",
          "K972352",
          "K130524",
          "K173772",
          "K162150",
          "K092817",
          "K041148",
          "K011668",
          "K221896",
          "K223185",
          "K973000",
          "K000316",
          "K193610",
          "K990931",
          "K093834",
          "K173777"
        ],
        "device_name": "Test, Urea (Breath Or Blood)",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3110",
        "device_class": "1",
        "registration_number": [
          "3005772418"
        ],
        "fei_number": [
          "3005772418"
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      }
    }
  ]
}