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Exent® analyser

Official notice

29 Apr 2026

MediumHealth Canada

An official Health Canada notice concerns Exent® analyser. 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. Published 2026-04-29.

What to do now

Contact the manufacturer if you require additional information.

Recall number

81992

Official notice

2026-04-29

The hazard

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.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Lots

A1280927

Skus

IE800

Other

RA RA-81992

Model Numbers

IE800

Recall Numbers

81992

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Affected products

Product 1

Lot or serial number - A1280927, Model or catalogue number - IE800

Risk / hazard

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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: The Binding Site.

Source & status

Source

Health Canada

Tier

beta

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

81992

Classification

Type II

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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