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Health Canada Medical devices

DxC 500i Clinical Analyzer and DxI 9000 Access Immunoassay Analyzer

Issued September 26, 2025
Issue
Beckman Coulter has confirmed a software anomaly on the DxC 500i Clinical Analyzer and DxI 9000 Access Immunoassay Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results (R1, R2) and potential delays in reporting (R3), risking erroneous diagnoses if undetected
Hazard description
Performance
Product
Product name
DxC 500i Clinical Analyzer and DxI 9000 Access Immunoassay Analyzer
Reference
ID
RA-78147