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EXENT® Analyser — recall 81992

Health Canada — Medical Devices · Canada · 2026-04-29 · Type II

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Agency: Health Canada — Medical Devices
Recall identifier: 81992
Date of alert: 2026-04-29
Country / jurisdiction: Canada
Risk level: Type II
Risk type: recall
Product category: Chemistry
Product type: Medical devices

Reported risk: 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.

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/exentr-analyser

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

EXENT® Analyser — recall 81992

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