EXENT Analyser
The Binding Site is recalling the EXENT Analyser due to a software error that may cause inaccurate M-protein detection or measurements.
Contact your local Binding Site representative for assistance with software updates and to discuss the impact on previously processed samples.
Why it was recalled
The Binding Site is recalling the EXENT Analyser due to a software error where plates 2 and 3 were incorrectly marked as passed without undergoing quality control. This failure may result in false or missed detection of M-protein or inaccurate concentration measurements.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
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.
- UPC
- 05051700020886
- Recall #
- Z-2362-2026
Where it was sold
Distributed nationwide.
Official source
Editorial summary by Recall Canary · last updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification