Beckman Coulter Recalls UniCel Dxl 600 Analyzers Over Restart Issue
Beckman Coulter recalled 1,272 UniCel Dxl 600 analyzers on November 26, 2025. A communication issue may prevent the devices from restarting after shutdown, delaying test results. The recall affects multiple countries worldwide.
Quick Facts at a Glance
Recall Date
November 26, 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
Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.
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 Beckman Coulter UniCel Dxl 600 is an immunoassay analyzer used in healthcare settings to process patient samples for various tests, including cardiac markers like troponin. These analyzers are critical for delivering timely and accurate test results to healthcare professionals.
Why This Is Dangerous
The potential communication issue may cause the device to fail to restart, rendering it unable to process samples. This issue can disrupt clinical workflows and delay essential patient care.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
This recall significantly impacts healthcare facilities relying on the UniCel Dxl 600 for patient testing, leading to potential delays in diagnosis and treatment.
Practical Guidance
How to identify if yours is affected
Check the model number and part numbers against the recalled list: A71460, A71461, A30260.
Verify if the analyzer has experienced issues restarting after shutdown.
Consult the manufacturer or your healthcare provider for further information.
Where to find product info
Model numbers and part numbers can usually be found on the device's identification label or user manual.
What timeline to expect
Expect a response from Beckman Coulter regarding your inquiry within 4-6 weeks.
If the manufacturer is unresponsive
Follow up with Beckman Coulter via phone or email.
Document your communication attempts.
Consider filing a complaint with the FDA if no response is received.
How to prevent similar issues
Look for devices with reliable restart features and strong manufacturer support.
Check for recalls before purchasing laboratory equipment.
Ensure that devices meet current safety and performance standards.
Documentation advice
Keep records of your purchase, any communications with Beckman Coulter, and photographs of the device for your records.
Product Details
The recalled models are Beckman Coulter UniCel Dxl 600 with part numbers A71460, A71461, and A30260. These analyzers were distributed globally, including the US and countries such as Canada, Germany, and Australia.
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