Recall Z-2362-2026
- Recall number
- Z-2362-2026
- Event number
- 98830
- Firm
- The Binding Site Group, Ltd.
- Firm FEI
- 3002808340
- Product code
- OTA
- Status
- Open, Classified
- Initiated
- 2026-04-16
- Posted
- 2026-06-09
- Root cause
- Under Investigation by firm
- 510(k) numbers
- K250159
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 for Recall#
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.