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 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.
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.
This recall is not part of a broader industry pattern.
This recall significantly impacts healthcare facilities relying on the UniCel Dxl 600 for patient testing, leading to potential delays in diagnosis and treatment.
Model numbers and part numbers can usually be found on the device's identification label or user manual.
Expect a response from Beckman Coulter regarding your inquiry within 4-6 weeks.
Keep records of your purchase, any communications with Beckman Coulter, and photographs of the device for your records.
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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