The Binding Site Group, Ltd. recalls Brand Name: EXENT Analyser Product Name: EXENT Analyser
- Recalling company
- The Binding Site Group, Ltd.
- 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.
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Apr 16, 2026
- Reported
- Jun 17, 2026
- Distribution
- US Nationwide distribution.
- Status
- Ongoing
- Quantity
- 1
- Lot / codes
- Lot Code: Model No; IE800A; EXENT Analyser; UDI; 05051700020886, Serial Number; 101150, Software version; v1.0.20.
- Company location
- Birmingham, N/A
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2362-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2362-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.