{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "215868",
      "product_res_number": "Z-0412-2026",
      "event_date_initiated": "2025-09-08",
      "event_date_posted": "2025-10-30",
      "recall_status": "Open, Classified",
      "res_event_number": "97531",
      "product_code": "PER",
      "product_description": "CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E.",
      "code_info": "All serial numbers between BE43003 through BJ18014, manufactured from 12/03/2021 to 04/15/2025. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E.",
      "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": "Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassette Type/List volume/correct volume, B/750/1582 microliters, and E/1300/2093 microliters. Device software does not rock Cassette E, used with 15mmX92mm Sarstedt tubes. May lead to incorrect diagnosis or error in patient management/treatment.",
      "root_cause_description": "Software design",
      "action": "Beckman Coulter notified consignees via email and letter on about 09/08/2025.  \n\nFor Issue 1 (Incorrect Dead Volumes), consignees were instructed to use the actual specimen dead volumes stated in Issue Description in the notification letter when processing samples in CellMek SPS with Sarstedt brand tubes. Beckman Coulter recommends sharing the content of the notification letter with laboratory and/or medical director regarding the need to review previous patient test results that were generated using the Sarstedt brand tubes. Beckman Coulter also recommends posting this letter on or near the affected instruments. Beckman Coulter will provide the correct CellMek SPS specimen dead volumes for Sarstedt brand tubes (Cassette Types B and E) in the next revision of the CellMek SPS Instructions for Use\n\nFor Issue 2 (), consignees were instructed not to use Cassette Type E (15mm X 92mm Sarstedt brand tubes) to process samples on CellMek SPS. Beckman Coulter recommends sharing the content of the notification letter with laboratory and/or medical director regarding the need to review previous patient test results that were generated using the Sarstedt brand tubes. Beckman Coulter recommends posting the notification letter on or near the affected instruments. Beckman Coulter is actively investigating this issue and plans to address it in a future product release.\n\nAdditionally, customers were instructed to notify personnel/customers if any affected units were transferred/distributed to another laboratory, and to complete and return the response form.",
      "product_quantity": "108 units",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of AL, AR, FL, IL, IN, MA, ME, MI, MN, MO, NY, OR, TN, UT, WA and the countries Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Korea, Republic of, Mexico, Morocco, Netherlands, Poland, Portugal, Puerto Rico, South Africa, Spain, Switzerland, United Kingdom of Great Britain and Northern Ireland.",
      "openfda": {
        "k_number": [
          "K130253",
          "K050191",
          "K131301"
        ],
        "registration_number": [
          "3013058950",
          "3027394506",
          "3020704087",
          "1061932",
          "2024375",
          "8043379",
          "9613959",
          "3014150341",
          "3038611403",
          "3003537036",
          "3010421384",
          "3010194621",
          "3009711478",
          "3008494306"
        ],
        "fei_number": [
          "3013058950",
          "3027394506",
          "3003413192",
          "3020704087",
          "2024375",
          "3014150341",
          "3038611403",
          "3000203293",
          "3003537036",
          "3010421384",
          "3010194621",
          "3009711478",
          "3002808301",
          "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"
      }
    }
  ]
}