{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "159026",
      "product_res_number": "Z-0091-2018",
      "event_date_initiated": "2017-10-02",
      "event_date_created": "2018-10-11",
      "recall_status": "Terminated",
      "event_date_terminated": "2019-05-08",
      "res_event_number": "78256",
      "product_code": "OYE",
      "k_numbers": [
        "K141932"
      ],
      "product_description": "AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx.   The firm name on the label is Beckman Coulter Ireland Inc., Ireland.\n\nThe AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping. It is used in conjunction with the following reagents and software package: AQUIOS Tetra-1 Panel monoclonal antibody reagents, AQUIOS Tetra-2+ Panel monoclonal antibody reagents, and AQUIOS CL Flow Cytometry Software.",
      "code_info": "All existing software versions (2.0, 2.0.1, and 2.1).",
      "firm_fei_number": "2050012",
      "recalling_firm": "Beckman Coulter Inc.",
      "address_1": "250 S Kraemer Blvd",
      "city": "Brea",
      "state": "CA",
      "postal_code": "92821-6232",
      "additional_info_contact": "Aruna Badiga, Ph. D.\n305-380-4189",
      "reason_for_recall": "The system may duplicate sample requests leading to sample misidentification when connected to a Laboratory Information System (LIS)",
      "root_cause_description": "Software design",
      "action": "Beckman Coulter sent an Urgent Medical Device Recall letter dated September 28, 2017,  and via phone on October 4, 2017.   On 11/30/2017, the firm issued an updated letter dated 11/28/2017.  The letter informs the customer this letter replaces the instructions in the original notification dated 9/28/2017.",
      "product_quantity": "268 units",
      "distribution_pattern": "Worldwide Distribution - US Distribution to the states of :  AZ, CA, CO, FL, GA, IL, IN, KS, NC, NY, OR, PA, SC, TX, and WA, including  Puerto Rico and government distribution, and to the countries of : Canada, Angola, Australia, Belgium, Botswana, Brazil, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Ghana, Hong Kong, India, Israel, Italy, Kenya, Lesotho, Malawi, Malaysia, Mexico, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Uganda, Ukraine, United Kingdom, and Zambia.",
      "openfda": {
        "k_number": [
          "K201814",
          "K141468",
          "K130373",
          "K232600",
          "K121445",
          "K170974",
          "K162897",
          "K141932"
        ],
        "registration_number": [
          "8023018",
          "8043379",
          "3008494306",
          "1017835",
          "3003589956",
          "3003244710",
          "3016954941",
          "1064130",
          "3027394506",
          "1061932",
          "3008352382"
        ],
        "fei_number": [
          "3000203293",
          "3008494306",
          "3003589956",
          "3003413192",
          "3002684533",
          "3003244710",
          "3016954941",
          "1017835",
          "3027394506",
          "3002807272",
          "3008352382"
        ],
        "device_name": "Flow Cytometric Reagents And Accessories.",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.5220",
        "device_class": "2"
      }
    }
  ]
}