{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "216127",
      "product_res_number": "Z-0541-2026",
      "event_date_initiated": "2025-09-22",
      "event_date_posted": "2025-11-18",
      "recall_status": "Open, Classified",
      "res_event_number": "97624",
      "product_code": "OYE",
      "k_numbers": [
        "K232600"
      ],
      "product_description": "DxFLEX Flow Cytometer Catalog Number C78500\nUDI-DI code: 15099590754013\n\nThe DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping up to ten fluorescent detection channels using three lasers (488 nm, 638 nm and 405 nm) and two light scatter detection channels. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument.",
      "code_info": "Catalog Number: C78500\nUDI-DI code: 15099590754013\nSerial Numbers:\nBH44060, BJ09004, BJ14015, BJ09010, BJ13012, BJ14014, BJ13011, BJ14017, BJ13013, BJ09003, BJ09008, BJ09009, BH39057, BH44059, BJ14016, BJ05002, BJ17020, BJ17021, BH26031, BJ19024, BJ09005, BJ09006, BJ09007, BJ19022, BJ19023",
      "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": "Kristin Godfredsen\n760-419-7078",
      "reason_for_recall": "Due to a software error code that crashes during acquisition on patient sample when running customer defined acquisition protocol. This may lead to delayed patient results.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On 09/22/2025. an Urgent Medical Device Recall letter was sent via postal mail and/or email informing customers that Beckman Coulter has determined that the DxFLEX software version 2.3.4.37 may crash due to a code error issue.While using the DxFLEX Flow Cytometer instrument for data acquisition using user defined acquisition protocol, the CytExpert for DxFLEX software (version 2.3.4.37) may unexpectedly crash. Due to that, the data acquisition may not be completed according to the preset conditions (i.e., number of events and/or acquisition time). When the software crash is not detected promptly, the sample may be completely consumed.\n\nCustomers are instructed to:\n Follow the steps below when running experiments in the instrument until the software is upgraded to the version that will fix the issue:\na. Prepare the experiment file (create sample, set location, etc.)\nb. Switch to first  Tube  sheet for each task to be acquired\nc. Save and close the experiment file\nd. Open the experiment again (DO NOT switch to REPORT sheet after opening experiment) This step will prevent the software from crashing due to this code error issue.\ne. Perform acquisition\nf. Analyze data.\n\" Beckman Coulter recommends posting this letter on or near the affected analyzers until the update to the software that addresses this issue is completed.\n\nFor questions: contact our Customer Support Center\n\" From our website: http://www.beckman.com\n\" By phone: call (800) 369-0333 in the United States.",
      "product_quantity": "25 units",
      "distribution_pattern": "Worldwide - U.S. Nationwide distribution in the states of CA, CT, FL, IL, NY, OH, OR, TN, and TX. The country of India.",
      "openfda": {
        "k_number": [
          "K130373",
          "K201814",
          "K121445",
          "K141468",
          "K170974",
          "K141932",
          "K162897",
          "K232600"
        ],
        "registration_number": [
          "3008352382",
          "8043379",
          "3016954941",
          "3027394506",
          "1061932",
          "3003589956",
          "3003244710",
          "1017835",
          "3008494306",
          "1064130",
          "8023018"
        ],
        "fei_number": [
          "3002684533",
          "3002807272",
          "3008352382",
          "3003413192",
          "3016954941",
          "3000203293",
          "3027394506",
          "1017835",
          "3003244710",
          "3008494306",
          "3003589956"
        ],
        "device_name": "Flow Cytometric Reagents And Accessories.",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.5220",
        "device_class": "2"
      }
    }
  ]
}