Beckman Coulter recalled the UniCel DxH 600 Cellular Analysis System on August 13, 2025. The devices may produce erroneously high hemoglobin results in patients with elevated white blood cell counts. This recall affects medical facilities worldwide, including the United States.
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 600 COULTER Cellular Analysis System configured with the Led HGB Photometer, REF: B23858. The affected models include UDI: 15099590192242 and several serial numbers such as AV52143, AZ02628, and others. The product was distributed in various countries, including the US and regions across Europe and Asia.
The hematology analyzers may yield erroneously high hemoglobin results for samples with elevated white blood cell counts. This could potentially lead to misdiagnosis or inappropriate treatment for patients. The risk level is classified as high.
As of the recall date, no specific incidents or injuries have been reported. The nature of the hazard indicates a significant risk for misdiagnosis.
Patients and healthcare providers must stop using the affected devices immediately. Follow the manufacturer's recall instructions and contact Beckman Coulter Inc. or your healthcare provider for further guidance.
For more information, contact Beckman Coulter Inc. via email or visit their website. Additional details can be found at the FDA recall page.
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