BEUDAMED
    FDA Recall Terminated

    BD Viper LT software, version 3.00H

    Recall: Z-1866-2017 · Initiated December 14, 2015

    Recall

    Recall Number
    Z-1866-2017
    Event Number
    76895
    Firm
    Bd Diagnostic
    FEI Number
    1119779
    Product Code
    OOI
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 14, 2015
    Posted
    April 4, 2017
    Terminated
    April 19, 2017
    Address
    54 Loveton Circle, Mc 912, Sparks, MD, 21152

    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.

    Action

    Recall action was initiated on December 14, 2015 when software version 3.00H was removed from the two customer instruments. The 2 affected US customers were contacted via email and were also mailed a letter via UPS overnight express.

    Distribution

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

    Quantity

    2