BEUDAMED
    FDA Recall Open, Classified

    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.

    Recall: Z-2362-2026 · Initiated April 16, 2026

    Recall

    Recall Number
    Z-2362-2026
    Event Number
    98830
    Firm
    The Binding Site Group, Ltd.
    FEI Number
    3002808340
    Product Code
    OTA
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 16, 2026
    Posted
    June 9, 2026
    Address
    8 Calthorpe Road, Birmingham United Kingdom

    Description

    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

    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

    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.

    Distribution

    US Nationwide distribution.

    Quantity

    1