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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Beckman Coulter DxFLEX Flow Cytometers Recalled for Software Crash Risk

Agency Publication Date: November 18, 2025
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Summary

Beckman Coulter Inc. has recalled 25 units of the DxFLEX Flow Cytometer (Catalog Number C78500) due to a software error. The software may crash during the acquisition of patient samples when running specific custom-defined protocols, leading to system failures. This issue can result in significant delays for patient test results and requires a software correction from the manufacturer.

Risk

The software crash halts the analysis of patient samples, which may delay clinical diagnosis and patient care decisions. No injuries or incidents have been reported to date.

What You Should Do

  1. This recall affects the DxFLEX Flow Cytometer with Catalog Number C78500 and UDI-DI code 15099590754013.
  2. Check the serial number on your device to determine if it is one of the 25 affected units. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product for any acquisition protocols that may trigger this software crash. Contact Beckman Coulter Inc. or your distributor to arrange for a software update, repair, or correction.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) if you have additional questions regarding this medical device recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: DxFLEX Flow Cytometer
Model / REF:
C78500
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
Lot Numbers:
15099590754013
UDI:
15099590754013

The DxFLEX Flow Cytometer is an in vitro diagnostic device for immunophenotyping.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97624
Status: Active
Manufacturer: Beckman Coulter Inc.
Sold By: authorized distributors
Manufactured In: United States
Units Affected: 25 units
Distributed To: California, Connecticut, Florida, Illinois, New York, Ohio, Oregon, Tennessee, Texas

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. 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. Refer to the openFDA terms of service for more information.