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 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.
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.
This recall is not part of a broader industry pattern.
Healthcare providers relying on these devices for timely results may face operational delays, impacting patient care and treatment timelines.
The part and UDI numbers can typically be found on the device's identification plate or user manual.
Expect a response regarding replacements or refunds within 4-6 weeks after contacting Beckman Coulter.
Keep a detailed record of all communications related to the recall, including emails and phone call notes.
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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