{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "215546",
      "product_res_number": "Z-2552-2025",
      "event_date_initiated": "2025-07-17",
      "event_date_posted": "2025-09-11",
      "recall_status": "Open, Classified",
      "res_event_number": "97419",
      "product_code": "PCL",
      "product_description": "Brand Name: ReQuest Measles IgM\nProduct Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM\nModel/Catalog Number: 01-190M\nSoftware Version: N/A\nProduct Description: Measles IgM tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presence of IgM antibodies against measles virus in a patient's serum or plasma\nComponent: not a component",
      "code_info": "UDI I# 00850487007104 - \nLots affected: G00024; K04024; M11024; M12024; D01025; E04025,F04025",
      "firm_fei_number": "3000206132",
      "recalling_firm": "Quest International, Inc.",
      "address_1": "8127 Nw 29th St",
      "city": "Doral",
      "state": "FL",
      "postal_code": "33122-1051",
      "additional_info_contact": "Steve Andrus\n+1-772-2836540",
      "reason_for_recall": "Measles IgM Test Kit lacks  premarket approval or clearance.",
      "root_cause_description": "No Marketing Application",
      "action": "On July 17, 2025, Quest International, Inc. issued a \"Urgent: Medical Device Recall Notification to affected consignees via E-Mail. Quest International  asked consignees to take the following actions:\n\n1. Please examine your inventory and quarantine the affected lot. In addition, if you have distributed the product, you must identify all customers that have received the affected product and immediately notify them. \n\n2. Please ask your customers to discontinue the use of the affected product(s) lot of the Measles IgM Test Kit immediately. \n\n3. We ask that you and your customers discard all affected products in accordance with all local, state, and federal disposal procedures. \n\n4. Please complete and return the enclosed Medical Device Recall Response Form as soon as possible.",
      "product_quantity": "376 kits",
      "distribution_pattern": "US Nationwide distribution in the states of Utah, Texas, and Arizona.",
      "openfda": {
        "device_name": "Enzyme Linked Immunoabsorbent Assay, Rubeola Igm",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3520",
        "device_class": "1",
        "registration_number": [
          "1318354",
          "2029372"
        ],
        "fei_number": [
          "1318354",
          "1000306617"
        ],
        "k_number": [
          "K140455"
        ]
      }
    }
  ]
}