Skip to content

DxFLEX Flow Cytometer Catalog Number C78500 recallZ-0541-2026 · Beckman Coulter Inc. · initiated Sep 22, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Beckman Coulter Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-0541-2026
Status
Open, Classified
Initiated by the company
Sep 22, 2025
Posted by the FDA
Nov 18, 2025
Recalling firm
Beckman Coulter Inc.
Quantity
25 units
Product code
OYE
FDA submissions
K232600
Distribution
Worldwide - U.S. Nationwide distribution in the states of CA, CT, FL, IL, NY, OH, OR, TN, and TX. The country of India.

Product description

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 (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page