CanadaThe EXENT® Analyser (model IE800, serial A1280927) from The Binding Site Group Limited is affected. A software issue can cause quality control to be shown as complete when it was not, potentially allowing unverified results to be reported. Users are advised to review QC results and audit logs to confirm QC was performed and to contact the manufacturer for additional information.
What's being recalled
Companies: The Binding Site Group Limited, 8 Calthorpe Road, Birmingham, United Kingdom, B15 1QT.
How to identify it
Affected products: EXENT® Analyser; Lot or serial number: A1280927; Model or catalogue number: IE800
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)