# FDA recall Z-2362-2026

> **The Binding Site Group, Ltd.** · Class II · device recall initiated 2026-04-16.

## 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.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2362-2026
- **Recalling firm:** The Binding Site Group, Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-04-16
- **Report date:** 2026-06-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Birmingham, N/A, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2362-2026

## Citation

> MORVS. FDA recall Z-2362-2026. Retrieved 2026-10-19 from https://api.morvs.ai/recall/Z-2362-2026. Source: US FDA. Licensed CC0.

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