Beckman Coulter Inc. is recalling several UniCel DxH COULTER Cellular Analysis System models, specifically the 900, 690T, 800, and 600 series, when configured with the Led HGB Photometer. Internal evaluations discovered that these laboratory analyzers may produce incorrectly high hemoglobin (HGB) results when testing blood samples that have elevated white blood cell (WBC) counts. The manufacturer notified affected clinical laboratories and healthcare facilities worldwide via email starting August 13, 2025.
The reported hemoglobin levels may be higher than they actually are in patients with high white blood cell counts, which can lead to the failure to diagnose anemia or result in inappropriate medical treatment. No specific patient injuries have been reported at this time.
Recall #: Z-2572-2025
Recall #: Z-2573-2025
Recall #: Z-2574-2025
Recall #: Z-2575-2025
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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