BEUDAMED
    FDA Enforcement Class II Terminated

    Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), For use in determining quantitative and/or qualitative antimicrobial agent susceptibility.

    Recall: Z-1525-2013 · Reported June 19, 2013

    Enforcement

    Recall Number
    Z-1525-2013
    Event ID
    65188
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 19, 2013
    Initiation Date
    May 2, 2013
    Classification Date
    June 8, 2013
    Termination Date
    September 17, 2013
    Address
    2040 Enterprise Blvd, N/A, West Sacramento, CA, 95691-3427, United States

    Description

    Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), For use in determining quantitative and/or qualitative antimicrobial agent susceptibility.

    Reason

    The product has the potential for false negative or delayed reaction for Arginine (ARG) results. In addition, 42 hour identification panel holds may occur due to a weak ARG reaction.

    Code Info

    Lot: 2013-11-13, Exp 11/13/2013.

    Distribution

    Nationwide Distribution.

    Quantity

    683 units