{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
    }
  },
  "results": [
    {
      "cfres_id": "218939",
      "product_res_number": "Z-1893-2026",
      "event_date_initiated": "2026-03-13",
      "event_date_posted": "2026-04-17",
      "recall_status": "Open, Classified",
      "res_event_number": "98502",
      "product_code": "DOF",
      "k_numbers": [
        "K052549"
      ],
      "product_description": "(1)(2) LeadCare II Blood Lead Test Kit, (3)LeadCare II 5X Blood Lead Test Kit, (4)LeadCare II 9X Blood Lead Test Kit ;\nCatalog Number(s): (1) 70-6762, (2) 70-6762RUO, (3) 70-8404 (Box containing 5 Test Kits), (4) 70-9000 (Box containing 9 test kits);\nThe LeadCare II kit is provided with the following materials: \n\"\tSensors (2 Containers of 24 sensors each; 48 tests) \n\"\tTreatment Reagent Tubes (2 packages of 24 tubes each; 48 tests)\n\"\tHeparinized Capillary Tubes/Plungers (50 @)\n\"\tTransfer Droppers (50 @)\n\"\tCalibration Button (1 @)\n\"\tLead Control Level 1 (1 @ 2 mL)\n\"\tLead Control Level 2 (1 @ 2 mL)",
      "code_info": "Catalog Number(s): (1) 70-6762, (2) 70-6762RUO;\nUDI-DI: 00850355006000;\nALL lots and ALL sublots;\n\nCatalog Number(s): (3) 70-8404;\nUDI-DI: 00850355006086;\nALL lots and ALL sublots;\n\nCatalog Number(s): (4) 70-9000;\nUDI-DI: 00850355006093;\nALL lots and ALL sublots;",
      "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": "Magellan Diagnostics, Inc. Technical Services \n800-272-0102",
      "reason_for_recall": "Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.",
      "root_cause_description": "Device Design",
      "action": "On March 13, 2026, MEDICAL DEVICE FIELD CORRECTION letters were sent to customers.\nREQUIRED ACTIONS:\nThis field action does NOT require removal of product from the field. The LeadCare Test Systems continue to perform as intended when used according to the product labeling and Instructions for Use.\nThe regulatory status of all products noted above remains unchanged and the product supply uninterrupted. Technical and customer support will continue as normal.\nLEADCARE II: The only blood collection devices validated for use with the Magellan LeadCare II Blood Lead Test Kit are the capillary tubes provided in the LeadCare II Test Kit. No other collection device should be used for blood sample collection for testing with the LeadCare II System.\nLEADCARE PLUS AND ULTRA: End users must validate the use of micro-collection devices with LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems in accordance with their laboratory policies and procedures.\nREGARDING PREVIOUS RESULTS: Patients who have had elevated results when tested on the LeadCare Blood Lead Test Systems (LeadCare II, LeadCare Plus, and LeadCare Ultra) should have confirmatory testing performed in accordance with CDC or other applicable standards and guidelines.",
      "product_quantity": "197893",
      "distribution_pattern": "Worldwide - US Nationwide and the countries of Argentina, Australia, Bhutan, Bolivia, Canada, Chile, Diego Garcia, Ecuador, Eritrea, Georgia, Ghana, Guam, Guatemala, Haiti, Hong Kong, India, Indonesia, Israel, Italy, Ivory Coast, Japan, Kyrgyzstan, Mexico, Nepal, Peru, Philippines, South Africa, South Korea, Spain, UAE, Uruguay, Vietnam.",
      "openfda": {
        "k_number": [
          "K123563",
          "K936060",
          "K843839",
          "K971640",
          "K052549",
          "K142705"
        ],
        "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"
      }
    }
  ]
}