{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Brea",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "95285",
      "recalling_firm": "Beckman Coulter Inc.",
      "address_1": "250 S Kraemer Blvd",
      "address_2": "",
      "postal_code": "92821-6232",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S.:  AZ, CA, CO, FL, GA, HI, IL, MA, MI, MO, ND, NY, OH, PA,  and TX  O.U.S.: Australia, Belgium, Brazil, Chile, China, Czechia, Ecuador, France, Germany, Greece, Hong Kong, India, Italy, Kuwait, Mexico, Philippines, Poland, Portugal, Saudi Arabia, Slovakia, Spain, Sweden, Taiwan Province of China, and Turkey,",
      "recall_number": "Z-0118-2025",
      "product_description": "IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610    IGM reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 1, is intended for the quantitative determination of immunoglobulin M (IGM) in human serum by rate nephelometry.",
      "product_quantity": "12,102 reagents",
      "reason_for_recall": "Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU",
      "recall_initiation_date": "20240731",
      "center_classification_date": "20241017",
      "report_date": "20241023",
      "code_info": "Catalog Number: 447610 UDI-DI code: 15099590221195 Lot Numbers: M307362 M309410",
      "more_code_info": ""
    }
  ]
}