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Health Canada Medical devices

UniCel DxI 600 and 800 Access Immunoassay Systems

Issued December 16, 2025
Issue
Beckman Coulter UniCel DxI 600 and 800 instruments fail to start after rebooting because the AuObj.exe software does not launch. A specific LED pattern on MCC cards confirms a hardware startup fault. This non-conformance requires FSE intervention.
Hazard description
Performance
Product
Product name
UniCel DxI 600 and 800 Access Immunoassay Systems
Reference
ID
RA-81368