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The Binding Site Group, Ltd. recalls Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Produ
Recalled June 17, 2026 · FDA recall Z-2362-2026 · The Binding Site Group
Hazard
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. · FDA Class II
Units
1
Sold at
US Nationwide distribution.
Description
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.
Product
Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product Description: The 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.
Manufacturer(s)
The Binding Site Group, Ltd.
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →