{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "217890",
      "product_res_number": "Z-1235-2026",
      "event_date_initiated": "2025-12-23",
      "event_date_posted": "2026-02-02",
      "recall_status": "Open, Classified",
      "res_event_number": "98207",
      "product_code": "PER",
      "product_description": "CellMek SPS Sample Preparation System, REF: C44603, with software",
      "code_info": "UDI-DI: 15099590750312. Software Version 2.3.90.0",
      "firm_fei_number": "3000203293",
      "recalling_firm": "Beckman Coulter, Inc.",
      "address_1": "11800 Sw 147th Ave",
      "city": "Miami",
      "state": "FL",
      "postal_code": "33196-2500",
      "additional_info_contact": "Kristin Godfredsen\n760-419-7078",
      "reason_for_recall": "Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or touching tube bottoms, which could dislodge fluid line, result in sample loss, spillage, make instrument inoperable and will lead to unintentional removal of 60-100 microliters from final sample, may lead to incorrect diagnosis or patient management.",
      "root_cause_description": "Software change control",
      "action": "On 12/23/2025, recall notices were mailed and emailed to customers who were asked to do the following:\n1) To mitigate the risk of contact between the dispense probe and the tube bottom, utilize CellMek SPS output tubes distributed by Beckman Coulter.\n\n2) For absolute count assays, use the CellMek SPS on-board counting bead feature. Do not add counting beads to samples manually after preparation with CellMek SPS.\n\n3) Share the content of this letter with your laboratory and/or medical director regarding the need to review previous patient test results. If you have forwarded any of the affected product listed above to another laboratory, please provide them a copy of this letter.\n\n4) Firm recommends posting this letter on or near the affected instruments.\n\n5) Complete and return the response form.\n\nFirm will perform an on-site service modification to update your instrument software to correct this issue.\n\nIf you have any questions regarding this notice, please contact the firm's Customer Support Center: http://www.beckman.com, (800) 369-0333",
      "product_quantity": "50",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of MO, WA, MA, IL, AL, OR, IL and the countries of AB, BE, ES, FR, NL, ON, DE, AT, VIC, AU, GB, SK, MX, CH.",
      "openfda": {
        "k_number": [
          "K130253",
          "K050191",
          "K131301"
        ],
        "registration_number": [
          "3010194621",
          "3027394506",
          "9613959",
          "3010421384",
          "3038611403",
          "8043379",
          "3009711478",
          "3003537036",
          "1061932",
          "3020704087",
          "3014150341",
          "2024375",
          "3013058950",
          "3008494306"
        ],
        "fei_number": [
          "3010194621",
          "3002808301",
          "3027394506",
          "3010421384",
          "3038611403",
          "3009711478",
          "3003537036",
          "3020704087",
          "3003413192",
          "3000203293",
          "3014150341",
          "2024375",
          "3013058950",
          "3008494306"
        ],
        "device_name": "Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.2750",
        "device_class": "1"
      }
    }
  ]
}