The Binding Site Group recalls

Recall found. The Binding Site Group is named in FDA Class II recall Z-2362-2026 covering Brand Name. Hazard: 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. Identifying details: Lot Code: Model No; IE800A; EXENT Analyser; UDI; 05051700020886, Serial Number; 101150, Software version; v1.0.20.. Status: Ongoing.

Models with recalls

Brand Name (1)

All The Binding Site Group recalls

FDA Class II · Medical device · June 17, 2026

Brand Name recall — The Binding Site Group, Ltd.

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 clini…

Official ID Z-2362-2026 · Official record ↗

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FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Compiled from official public-domain government data. Last checked October 22, 2026 at 6:00 PM UTC.