BEUDAMED
    FDA Enforcement Class II Terminated

    The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usage: The Optilite Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used.

    Recall: Z-2071-2020 · Reported May 27, 2020

    Enforcement

    Recall Number
    Z-2071-2020
    Event ID
    85492
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    The Binding Site Group, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 27, 2020
    Initiation Date
    April 9, 2020
    Classification Date
    May 21, 2020
    Termination Date
    August 19, 2022
    Address
    8 Calthorpe Road, N/A, Birmingham, N/A, N/A, United Kingdom

    Description

    The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usage: The Optilite Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used.

    Reason

    A software issue that may affect the analyzer's result accuracy.

    Code Info

    Analyzers running with software version 7.0 or 7.01

    Distribution

    US Nationwide distribution including in the states of AL, AR, CA, FL, IL, IN, KS, KY, MA, MN, NC, NE, OH, PA, TX and VA.

    Quantity

    36