🇨🇦 UniCel DxI 600 Access Immunoassay System-Total T4 Assay

Hazard/Reason: 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.  

This page links to official sources. Verify model/lot/batch details in the official notice.