Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product D

FDA device recall Z-2362-2026 · posted 2026-06-09 · Open, Classified

Recall details

Recalling firm

The Binding Site Group, Ltd.

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.

Action taken

Firm notified customers via "Urgent Medical Device Correction" letter dated April 14, 2026. Customers were advised to confirm QC results are present in the QC results screen for the corresponding plate barcode after the completion of each plate measurement. If no QC result is displayed, do not release results from that plate and repeat the run ensuring QC material is properly loaded. The customer should also contact US Technical Support. When performing multi-plate runs while loading a previously used QC vials, ensure newly opened QCs are loaded onto Reagent Runner 2 as well, or discard and load newly opened QC vials into Reagent Runner 1. Retrospective review of previously released results is not considered necessary by the recalling firm. Please maintain awareness of the issue until Thermo Fisher Scientific identifies and implements a software enhancement that addresses the issue.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

OTA

Quantity affected

1

Distribution

US Nationwide distribution.

Date initiated

2026-04-16

Date posted

2026-06-09

Location

Birmingham, United Kingdom

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