Beckman Coulter recalled its UniCel DxH 800 COULTER Cellular Analysis System on August 13, 2025. This recall affects devices that may produce inaccurately high hemoglobin results in patients with high white blood cell counts. The recall impacts worldwide distribution including numerous states in the U.S. and many countries.
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
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: E-Mail
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The recall involves the UniCel DxH 800 COULTER Cellular Analysis System configured with the LED HGB Photometer. The affected model references include B24802, 629029, and B63322. Exact quantities recalled are not specified.
The hematology analyzers may yield erroneously high hemoglobin results in patients with elevated white blood cell counts. This issue can lead to misdiagnosis or inappropriate treatment.
No specific incidents were reported in the recall data. The potential for misdiagnosis poses a serious health risk.
Stop using the UniCel DxH 800 immediately. Healthcare providers should follow the recall instructions from Beckman Coulter Inc. Contact the company or your healthcare provider for further guidance.
Reach Beckman Coulter Inc. via email for assistance. For more information, visit the FDA recall page at the provided URL.
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