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.
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.
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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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.
The analyzers may not restart successfully after a standard shutdown. This defect prevents the device from processing patient samples and quality controls, leading to delayed medical results.
No specific incidents or injuries have been reported, but the potential for delayed medical results poses a high-risk situation for patient care.
Stop using the affected analyzers immediately. Contact Beckman Coulter or your healthcare provider for detailed instructions on the recall.
For more information, contact Beckman Coulter, Inc. at 1-800-xxxx-xxxx or visit their website at www.beckmancoulter.com.
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