Beckman Coulter recalled the UniCel DxH 900 COULTER Cellular Analysis System on August 13, 2025, due to erroneous high hemoglobin results. The devices may misreport hemoglobin levels on samples with elevated white blood cell counts. This recall affects devices distributed worldwide, including the U.S.
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 900 COULTER Cellular Analysis System configured with the Led HGB Photometer, REF: C11478. The device was sold worldwide, including all U.S. states. Specific models affected include serial numbers BB33238, BB33239, and others.
The hematology analyzers can produce erroneously high hemoglobin results, leading to potential misdiagnosis and inappropriate treatment. This issue arises specifically with samples that have high white blood cell counts.
No specific incidents were reported in the recall notice. However, the potential for misdiagnosis raises significant health risks.
Stop using the device immediately. Follow the manufacturer's recall instructions and contact Beckman Coulter Inc. or your healthcare provider for guidance.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2572-2025.
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