Official recall record
EXENT® Analyser
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2026-04-29
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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