EXENT® Analyser
Brand(s)
Last updated
Summary
Product
EXENT® Analyser
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| EXENT® Analyser | A1280927 | IE800 |
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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies
The Binding Site Group Limited
8 Calthorpe Road, Birmingham, United Kingdom, B15 1QT
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-81992
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