What should I do if I have this product?

Stop using the CellMek SPS Sample Preparation System immediately and contact Beckman Coulter or your healthcare provider for further instructions.

What are the risks associated with this product recall?

The software error may lead to sample loss, which can result in incorrect diagnoses or patient management.

Will I receive a refund for the recalled device?

Follow the recall instructions provided by Beckman Coulter. Contact them directly to inquire about refund or replacement options.

How can I stay updated on this recall?

Check the FDA recall page for updates and further guidance on the recall.

What happens if I continue to use this device?

Continuing to use the device may result in sample loss and potentially incorrect diagnosis, which can impact patient care.

Is there a deadline to return the recalled device?

While no specific deadline is mentioned, it is advisable to stop using the product and contact the manufacturer as soon as possible.

Can this device cause harm to patients?

Yes, if the device dispenses samples incorrectly, it could lead to incorrect diagnoses, affecting patient management.

How does the software error occur?

The error causes samples to be dispensed too close to the bottom of the tubes, which can dislodge the fluid line.

Who should I contact for more information on the recall?

Contact Beckman Coulter, Inc. or your healthcare provider for the most accurate and detailed information regarding the recall.

HIGHDecember 23, 2025

Beckman Coulter Sample Preparation System Recalled for Software Error

Q: How can I find out if my device is affected?

Check if your device is the CellMek SPS Sample Preparation System, REF: C44603, with software version 2.3.90.0. If it matches, it is part of the recall.

Beckman Coulter recalled 50 units of the CellMek SPS Sample Preparation System on December 23, 2025. A software error causes sample dispensation issues leading to potential sample loss and incorrect diagnoses. Healthcare providers should stop using the device immediately.

Quick Facts at a Glance

Recall Date: December 23, 2025
Hazard Level: HIGH
Brand: Beckman Coulter
Category: Health & Personal Care
Sold At: Multiple Retailers
Geographic Scope: 1 states
At-Risk Groups: GENERAL

Hazard Information

Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or touching tube bottoms, which could dislodge fluid line, result in sample loss, spillage, make instrument inoperable and will lead to unintentional removal of 60-100 microliters from final sample, may lead to incorrect diagnosis or patient management.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Beckman Coulter, Inc. or your healthcare provider for instructions. Notification method: Letter

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About This Product

The CellMek SPS Sample Preparation System is designed to automate the processes of staining, lysing, and cell washing in laboratory settings. Healthcare professionals rely on this device for accurate sample preparation.

Why This Is Dangerous

The software error in the device causes samples to be dispensed improperly, which can lead to significant sample loss. This can disrupt test results, adversely affecting patient diagnosis and management.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Healthcare providers may experience operational disruptions due to the recall. The risk of incorrect diagnoses poses a serious concern for patient safety.

Practical Guidance

How to identify if yours is affected

Check the model number and software version of your sample preparation system.
Ensure your device is the CellMek SPS Sample Preparation System, REF: C44603.
Verify the software version is 2.3.90.0.

Where to find product info

The model number and software version can typically be found on the device's label or in the user manual.

What timeline to expect

Refund processing may take approximately 4-6 weeks after the recall is initiated.

If the manufacturer is unresponsive

Document your communication attempts with the manufacturer.
Consider filing a report with the FDA if the manufacturer does not respond.

How to prevent similar issues

Always verify the software version before using medical devices.
Stay informed about recalls and safety alerts regarding medical devices.

Documentation advice

Keep records of all correspondence regarding the recall, including emails, receipts, and any photos of the device.

Product Details

The recalled product is the CellMek SPS Sample Preparation System, REF: C44603, with software version 2.3.90.0. It was distributed in the US and several countries worldwide, with no specific price mentioned.

Key Facts

Recalled product: CellMek SPS Sample Preparation System
Quantity recalled: 50 units
Software error causes sample dispensing issues
Potential for incorrect diagnosis or patient management
Immediate stop-use recommended

View Original Recall on FDA - Medical Devices

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Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERAL

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeSample Preparation System

Product Details

Brand

Beckman Coulter

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