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Health Canada Medical devices

Unicel DxH Series Instruments

Issued August 20, 2025
Issue
Beckman Coulter has identified a potential for erroneously high hemoglobin (Hgb) results on samples with elevated white blood cell (WBC) counts. This occurs on Unicel DxH series instruments configured with the led Hgb photometer. Falsely elevated Hgb results may observed in specimens with WBC counts > 30 x 10³ cells/μl. Recall start date: August 6, 2025
Hazard description
Performance
Product
Product name
Unicel DxH Series Instruments
Reference
ID
RA-77942