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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Beckman Coulter
- Product type
- Sample Preparation System
- Model numbers
- UDI-DI: 15099590750312. Software Version 2.3.90.0
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 23, 2025
Reported by FDA DEVICE
February 11, 2026
RecallRadar source check
February 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
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.
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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
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Safety Guide
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