DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as
FDA device recall Z-0541-2026 · posted 2025-11-18 · Open, Classified
Recall details
- Recalling firm
- Beckman Coulter Inc.
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- OYE
- Quantity affected
- 25 units
- Distribution
- Worldwide - U.S. Nationwide distribution in the states of CA, CT, FL, IL, NY, OH, OR, TN, and TX. The country of India.
- Date initiated
- 2025-09-22
- Date posted
- 2025-11-18
- Location
- Brea, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DxFLEX Flow Cytometer; ClearLLab 10C Panels (K232600) | Beckman Coulter, Inc. | 2023-11-22 |