Recall Monitor
Health Products

EXENT® Analyser

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Chemistry
Product: EXENT® Analyser
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
EXENT® AnalyserA1280927IE800

Issue

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.

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