{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Miami",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97992",
      "recalling_firm": "Beckman Coulter, Inc.",
      "address_1": "11800 Sw 147th Ave",
      "address_2": "N/A",
      "postal_code": "33196-2500",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of Argentina, Canada, Chile, Mexico, Saint Kitts and Nevis, Trinidad and Tobago, and Viet Nam.",
      "recall_number": "Z-1221-2026",
      "product_description": "COULTER DxH Diluent, REF 628017  COULTER DxH ECO Diluent REF C67250    For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all UniCel DxH Coulter Cellular Analysis Systems. For use as a rinsing agent on the UniCel DxH Slidemaker Stainers.  For use as a diluent in conjunction with DxH ECO Cell Lyse for counting and sizing blood cells. For use as a rinsing agent.",
      "product_quantity": "76,098 units (US-61843 and OUS-14255)",
      "reason_for_recall": "Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.",
      "recall_initiation_date": "20251110",
      "center_classification_date": "20260130",
      "report_date": "20260211",
      "code_info": "Catalog Numbers: COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250  UDI-DI code: 15099590233686 Lot Numbers: 2510410 2510420 2510450 3557500 3557510 3557540 3557560 3557570 3557640 3557650 3557660 3557670 3557680 3557700 3557710 3557850 3557920 3557930 3558000 3558030 3558040 3558060 3558090 3558100 3558110 3558120 3558140 3558150 3558160 3558170"
    }
  ]
}