{
  "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": "2026-10-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "222454",
      "product_res_number": "Z-0162-2027",
      "event_date_initiated": "2026-09-04",
      "event_date_posted": "2026-10-15",
      "recall_status": "Open, Classified",
      "res_event_number": "99776",
      "product_code": "DOF",
      "k_numbers": [
        "K052549"
      ],
      "product_description": "LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.",
      "code_info": "Model/Catalog Number: 70-6762. UD-DI: 00850355006000. Lot Number. 2530M-01.",
      "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": "Ryan Spradling\n1-800-2750102",
      "reason_for_recall": "In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while the correct expiration date is July 13, 2026.  If used the system will display an error message and prevent the operator from running the test. Resulting in delayed results.",
      "root_cause_description": "Labeling Change Control",
      "action": "Magellan notified consignees on about September 4, 2026, via telephone call indicating a written notification of the recall would follow. On 09/17/2026, a notification letter was emailed to consignees with the following instructions: \n\n1. Complete, sign, and return the CONFIRMATION OF NOTIFICATION FORM. \n2. Review your inventory for the affected LeadCare II Blood Lead Test Kit lot identified.\n3. Immediately discontinue use of any remaining affected kits.\n4. Return any recalled product still in your possession to Magellan Diagnostics, Inc. for destruction.",
      "product_quantity": "321 units",
      "distribution_pattern": "US Nationwide distribution in the states of CA, IN, PA, TX, NE, IL, MA, MO, KY.",
      "openfda": {
        "k_number": [
          "K971640",
          "K123563",
          "K052549",
          "K142705",
          "K936060",
          "K843839"
        ],
        "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"
      }
    }
  ]
}