Beckman Coulter recalled the UniCel DxH 690T COULTER Cellular Analysis System on August 13, 2025. Erroneously high hemoglobin results may occur in patients with elevated white blood cell counts. Healthcare providers and patients must stop using the device immediately.
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
The recall involves the UniCel DxH 690T COULTER Cellular Analysis System with the Led HGB Photometer, REF: C34520. The affected models include UDI: 15099590729110 and serial numbers BD17734, BE12048, BE28105, BF14045, BF23096, BF46236, BG26135, BG50247, BH12019, and BH43168.
The hematology analyzers may provide falsely high hemoglobin readings on samples from patients with high white blood cell counts. This miscalculation could lead to inappropriate treatment decisions.
Currently, no specific incidents or injuries have been reported related to this issue. The potential for serious misdiagnosis remains a significant concern.
Patients and healthcare providers should stop using the device immediately. Follow the manufacturer's recall instructions and contact Beckman Coulter Inc. for further guidelines.
For assistance, contact Beckman Coulter Inc. via email or visit their website for more information on the recall.
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