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.
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 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.
The analyzers may fail to restart after a standard shutdown. This malfunction prevents them from processing patient samples and quality controls, which can lead to delayed medical results.
No injuries or deaths have been reported due to this malfunction. The device's failure to process samples could potentially harm patient care.
Stop using the UniCel Dxl 600 analyzers immediately. Contact Beckman Coulter or your healthcare provider for further instructions and follow the recall procedures.
For more information, contact Beckman Coulter, Inc. or visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1025-2026.
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