BEUDAMED
    FDA Recall 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 · Initiated May 2, 2013

    Recall

    Recall Number
    Z-1525-2013
    Event Number
    65188
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2919016
    Product Code
    LTT
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 2, 2013
    Posted
    June 8, 2013
    Terminated
    September 17, 2013
    Address
    2040 Enterprise Blvd, West Sacramento, CA, 95691-3427

    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.

    Action

    Siemens sent an Urgent Field Safety Notice dated May 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact your local Siemens Healthcare Diagnostics Representative for information concerning this notice.

    Distribution

    Nationwide Distribution.

    Quantity

    683 units