Beckman Coulter Recalls 6,457 Immunoassay Analyzers Over Restart Issues
Beckman Coulter recalled 6,457 UniCel Dxl 800 analyzers on November 26, 2025, due to potential restart failures. The defect prevents the devices from transitioning to Ready mode, delaying patient sample processing. Healthcare providers must stop using the devices immediately and follow recall instructions.
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 800 is a laboratory analyzer used for immunoassay testing, commonly utilized in healthcare settings to measure biomarkers such as troponin. These devices are essential for diagnosing conditions like heart attacks, making their reliable operation critical.
Why This Is Dangerous
The reported communication issue can prevent the analyzers from properly restarting, which means they cannot process any patient samples or quality controls. This leads to delays in obtaining important test results, which can adversely affect patient treatment.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Healthcare providers relying on these devices for timely results may face operational delays, impacting patient care and treatment timelines.
Practical Guidance
How to identify if yours is affected
Check the part number on your analyzer to see if it matches 973100, A71456, A71457, or A25288.
Verify the UDI numbers against those provided in the recall notice.
Contact Beckman Coulter for further verification if needed.
Where to find product info
The part and UDI numbers can typically be found on the device's identification plate or user manual.
What timeline to expect
Expect a response regarding replacements or refunds within 4-6 weeks after contacting Beckman Coulter.
If the manufacturer is unresponsive
Follow up with Beckman Coulter if you do not receive a response within a week.
Consider reaching out to regulatory bodies like the FDA for assistance.
How to prevent similar issues
Ensure any future medical devices are certified by recognized regulatory agencies.
Regularly check for updates on device recalls or safety notices from manufacturers.
Documentation advice
Keep a detailed record of all communications related to the recall, including emails and phone call notes.
Product Details
The recall affects Beckman Coulter UniCel Dxl 800 analyzers with part numbers 973100, A71456, A71457, and A25288. These devices were distributed worldwide, including the U.S. and various countries, from January 2023 to November 2025.
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