Class 2 Device Recall DxFLEX Flow Cytometer

• Date Initiated by Firm: September 22, 2025
• Date Posted: November 18, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0541-2026
• Recall Event ID: 97624
• 510(K)Number: K232600
• Product Classification: Flow cytometric reagents and accessories. - Product Code OYE
• Product: DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The 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 Information: Catalog Number: C78500 UDI-DI code: 15099590754013 Serial Numbers: BH44060, BJ09004, BJ14015, BJ09010, BJ13012, BJ14014, BJ13011, BJ14017, BJ13013, BJ09003, BJ09008, BJ09009, BH39057, BH44059, BJ14016, BJ05002, BJ17020, BJ17021, BH26031, BJ19024, BJ09005, BJ09006, BJ09007, BJ19022, BJ19023
• FEI Number: 2050012
• Recalling Firm/ Manufacturer: Beckman Coulter Inc.; 250 S Kraemer Blvd; Brea CA 92821-6232
• For Additional Information Contact: Kristin Godfredsen; 760-419-7078
• Manufacturer 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.
• FDA Determined Cause: 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. 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.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OYE