The Binding Site Group, Ltd.: Mass Spectrometer For Clinical Multiplex Test Systems
Recall Summary The EXENT Analyser, an automated blood testing device made by The Binding Site Group, Ltd., is being recalled because it can mark test plates as passed without actually performing quality control checks on them. This could result in incorrect M-protein test results—either missing the protein when it's present, incorrectly detecting it when it's not, or reporting wrong concentration levels. The device was distributed nationwide across all U.S. states.
- Recalling firm
- 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
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-16
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/09ebc97b-6860-419b-974f-e292c3fe85e5