Official recall record
Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product Description: The
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2026-04-16
- Country of alert
- United Kingdom
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 05051700020886
- Brand on record
- The Binding Site Group, Ltd.
What the authority reported
It was reported that plates 2 and 3 were marked as passed , although it appeared that QC had not been performed on these plates, despite samples being measured. The potential clinical hazards include false or missed detection of M-protein (false positive); and falsely elevated or decreased M-protein concentration.
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:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-09-16.
Record last checked against the registry on 2026-09-16.
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