{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "64512",
      "product_res_number": "Z-0043-2008",
      "event_date_initiated": "2007-09-20",
      "event_date_posted": "2007-10-18",
      "recall_status": "Terminated",
      "event_date_terminated": "2008-03-25",
      "res_event_number": "44909",
      "product_code": "DOF",
      "k_numbers": [
        "K052549"
      ],
      "product_description": "ESA LeadCare II Blood Test Kit,  6 test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A\nCatalog  Number: 70-7142",
      "code_info": "Lot number: 0704A",
      "firm_fei_number": "1218996",
      "recalling_firm": "Esa Biosciences, Inc.",
      "address_1": "22 Alpha Rd",
      "city": "Chelmsford",
      "state": "MA",
      "postal_code": "01824-4123",
      "additional_info_contact": "Harol Asp\n978-250-7000",
      "reason_for_recall": "Level 1 and Level 2 Control values were incorrectly assigned.",
      "root_cause_description": "Process design",
      "action": "ESA notifed  Distributors and End Users by telephone and letter on 9/20/07. Distributors and End Users will be informed of the Level 1 and 2 Control value assignment change. End Users will be sent a new Level 1 and 2 Control Vial\nlabel for each vial they originally received. Distributors will be asked to return all test kits in their inventory to ESA Biosciences.",
      "product_quantity": "2 kits",
      "distribution_pattern": "Nationwide and United Kingdom.",
      "openfda": {
        "k_number": [
          "K971640",
          "K142705",
          "K123563",
          "K936060",
          "K843839",
          "K052549"
        ],
        "registration_number": [
          "3012494290",
          "1218996",
          "3043226252"
        ],
        "fei_number": [
          "3012494290",
          "1218996",
          "3043226252"
        ],
        "device_name": "Lead, Atomic Absorption",
        "medical_specialty_description": "Clinical Toxicology",
        "regulation_number": "862.3550",
        "device_class": "2"
      }
    }
  ]
}