🇨🇦 EXENT® Analyser

Hazard/Reason: FSCA initiated due to a software issue affecting the EXENT® Analyser (IE800), whereby QC may not be performed but is indicated as complete under specific conditions, potentially allowing unverified results to be reported. Users are advised to review QC results and audit logs to confirm that QC has been performed.

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