Beckman Coulter Inc. recalls DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX…

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.

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. Customers are instructed to: Follow the steps below when running experiments in the instrument until the software is upgraded to the version that will fix the issue: a. Prepare the experiment file (create sample, set location, etc.) b. Switch to first Tube sheet for each task to be acquired c. Save and close the experiment file d. 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. e. Perform acquisition f. Analyze data. " Beckman Coulter recommends posting this letter on or near the affected analyzers until the update to the software that addresses this issue is completed. For questions: contact our Customer Support Center " From our website: http://www.beckman.com " By phone: call (800) 369-0333 in the United States.

• FDA enforcement recordOfficial FDA database entry for Z-0541-2026
• FDA 510(k) clearance · K232600The device's official FDA premarket clearance record
• FDA device classification · OYEOfficial FDA classification for this device type
• CFR regulation · 21 CFR 864.5220The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Beckman Coulter Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.