{
  "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": "2026-10-07",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Sunto-Gun",
      "state": "",
      "country": "Japan",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "99588",
      "recalling_firm": "Beckman Coulter Mishima K.K.",
      "address_1": "454-32",
      "address_2": "Higashino; Nagaizumi-Cho",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide - U.S. Nationwide distribution in the states of AR, CA, DE, FL, GA, GU, HI, IA, IL, IN, KS, KY, MN, MO, NC, NM, NY, OK, PA, SD, TX, and WI. The countries of Algeria, Australia, Belarus, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, China, Costa Rica, Croatia, Cyprus, Czechia, Egypt, France, Germany, Guatemala, Hungary, India, Ireland, Italy, Japan, Kazakhstan, Korea, Republic of, Latvia, Malaysia, Morocco, Myanmar, Nepal, Nigeria, Pakistan, Poland, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, South Africa, Taiwan, Province of China, Turkey, United Arab Emirates, and Viet Nam.",
      "recall_number": "Z-3332-2026",
      "product_description": "Systems/units containing affected software/SQL  BECKMAN COULTER CHEMISTRY ANALYZER AU480  REF / UDI-DI code:  B96692 / 14987666542965  B96693 / 14987666542972  B12183 / 14987666540671    The AU480 Chemistry Analyzer measure analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material, and other accessories. This system is for in vitro diagnostic use only.",
      "product_quantity": "492 units",
      "reason_for_recall": "Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the message  System Stopped By Fatal Error: DBConnectionError AlarmDB  when launching the instrument software, using PC pre-installed with Microsoft SQL Server 2022 Express. When this occurs, AlarmDB becomes unreadable and the instrument software cannot be started.  This causes a delay in obtaining patient results.",
      "recall_initiation_date": "20260803",
      "center_classification_date": "20260930",
      "report_date": "20261007",
      "code_info": "Products containing affected software: Item Numbers / UDI-DI codes: Item Number: B96692 UDI-DI code: 14987666542965  Item Number: B96693 UDI-DI code: 14987666542972  Item Number: B12183 UDI-DI code: 14987666540671  Item Number: N3151400 UDI-DI code: Due to the age of the device and the fact that it has exceeded its storage period, the UDI number is not available.)",
      "more_code_info": ""
    }
  ]
}