{"url_path":"/fda/device/recalls/Z-2362-2026","section_key":"summary","section_title":"DEVICE Recall: The Binding Site Group, Ltd. — 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.","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-04-16","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2362-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"The Binding Site Group, Ltd."},"word_count":147,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2362-2026\n\n**Recalling firm:** The Binding Site Group, Ltd.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-16\n**Report date:** 2026-06-17\n\n## Product\nBrand 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.\n\n## Reason\nIt 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.\n\n## Affected lots\nLot Code: Model No; IE800A; EXENT Analyser; UDI; 05051700020886, Serial Number; 101150, Software version; v1.0.20.\n\n## Distribution\nUS Nationwide distribution."}