Reported Jun 17, 2026 · Ongoing
Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product…
The Binding Site Group, Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: The Binding Site Group, Ltd. · 8 Calthorpe Road · Birmingham, N/A · N/A
Is this the product you have?
- Brand NameEXENT
- Analyser Product NameEXENT
- Analyser Model/Catalog NumberIE800
- A Software Version1.0.20
- Product DescriptionThe EXENT Analyser is an automated analyser intended for the qualitative and quantitative in vitro measurement of analytes in human body fluids used in conjunction with the EXENT assays
- Lot codes and dates
- Lot CodeModel No; IE800A; EXENT Analyser; UDI; 05051700020886, Serial Number; 101150, Software version; v1.0.20
- Amount recalled
- 1
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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