BEUDAMED
    FDA Enforcement Class II Terminated

    BD Viper LT software, version 3.00H

    Recall: Z-1866-2017 · Reported April 26, 2017

    Enforcement

    Recall Number
    Z-1866-2017
    Event ID
    76895
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bd Diagnostic
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 26, 2017
    Initiation Date
    December 14, 2015
    Classification Date
    April 19, 2017
    Termination Date
    April 19, 2017
    Address
    54 Loveton Circle Mc 912, N/A, Sparks, MD, 21152, United States

    Description

    BD Viper LT software, version 3.00H

    Reason

    BD has confirmed reports that lower than expected RFU values were generated on customer BD Viper LT Systems after the installation of software version 3.00H. As RFU values decrease, results approach the assay cutoff threshold which has the potential to impact test results.

    Code Info

    Catalog Number 443157 443153 443155 443156 442947 443902 Version Number 3.00H 3.00H

    Distribution

    2 US customers, 0 Ex-US regions, and 0 distributors 0.

    Quantity

    2