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Health Canada Medical devices

UniCel DxI 600 Access Immunoassay System-Total T4 Assay

Issued March 19, 2026
Issue
Access Total T4 calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. In the worst-case scenario, there is a medium safety risk associated with this issue due to the potential to cause false low patient results.
Hazard description
Performance
Product
Product name
UniCel DxI 600 Access Immunoassay System-Total T4 Assay
Reference
ID
RA-81777