{
  "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": "216773",
      "product_res_number": "Z-0584-2026",
      "event_date_initiated": "2024-02-23",
      "event_date_posted": "2025-11-21",
      "recall_status": "Open, Classified",
      "res_event_number": "97858",
      "product_code": "DOF",
      "k_numbers": [
        "K052549"
      ],
      "product_description": "The LeadCare II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood.\n\nThe LeadCare II Test Kit is provided with the following materials:\n\" Sensors (2 Containers of 24 sensors each; 48 tests)\n\" Treatment Reagent Tubes (2 packages of 24 tubes each; 48 tests)\n\" Heparinized Capillary Tubes/Plungers (50)\n\" Transfer Droppers (50)\n\" Calibration Button (1)\n\" Lead Control Level 1 (1 @ 2 mL)\n\" Lead Control Level 2 (1 @ 2 mL)",
      "code_info": "Product Name: LeadCare¿ II Blood Lead Test Kit;\nCatalog Number: 70-6762;\nImpacted Lot/Sublot Numbers: 2333M, 2333M-01, 2333M-02, 2333M-03, 2333M-04, 2333M-05, 2333M-06, 2333M-07, 2333M-08, 2333M-09, 2333M-10, 2333M-11;\nDevice Identifier: (01)00850355006000;",
      "firm_fei_number": "1218996",
      "recalling_firm": "Magellan Diagnostics, Inc.",
      "address_1": "101 Billerica Ave Bldg 4 101 Billerica Ave",
      "address_2": "Bldg 4",
      "city": "North Billerica",
      "state": "MA",
      "postal_code": "01862-1271",
      "additional_info_contact": "Vernon Brown\n800-305-0197",
      "reason_for_recall": "Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for lot 2333M. The use of mislabeled calibration Button with Lot #2333 can lead to delayed or erroneous high or erroneous low results.",
      "root_cause_description": "Labeling mix-ups",
      "action": "On March 3, 2024, MEDICAL DEVICE FIELD CORRECTION letters were sent to customers. Immediate Actions:\n1. Identify existing inventory of impacted product and suspend its distribution. 2. \nIdentify customers that received the impacted product and notify them about this field action. 3. Return remaining impacted product to Magellan Diagnostics, Inc. for destruction. To initiate the return process, ensure that you note the quantity of product to be returned on your Confirmation of Notification Form. Actions to Be Taken by Magellan: 1. Magellan Diagnostics will continue to investigate the cause of the labeling error and initiate appropriate preventive actions. 2. Magellan will replace unexpired impacted product upon request. Product will be replaced based on availability, and on a first-come first-served basis.",
      "product_quantity": "1,774 units",
      "distribution_pattern": "US Nationwide distribution.",
      "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"
      }
    }
  ]
}