BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported June 17, 2026

    Enforcement

    Recall Number
    Z-2362-2026
    Event ID
    98830
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    The Binding Site Group, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 17, 2026
    Initiation Date
    April 16, 2026
    Classification Date
    June 9, 2026
    Address
    8 Calthorpe Road, N/A, Birmingham, N/A, N/A, 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.

    Code Info

    Lot Code: Model No; IE800A; EXENT Analyser; UDI; 05051700020886, Serial Number; 101150, Software version; v1.0.20.

    Distribution

    US Nationwide distribution.

    Quantity

    1