BEUDAMED
    FDA Enforcement Class I Terminated

    Microscan plus Negative Combo 3 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.

    Recall: Z-2124-2013 · Reported September 18, 2013

    Enforcement

    Recall Number
    Z-2124-2013
    Event ID
    66058
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 18, 2013
    Initiation Date
    August 21, 2013
    Classification Date
    September 11, 2013
    Termination Date
    May 15, 2014
    Address
    2040 Enterprise Blvd, N/A, West Sacramento, CA, 95691-3427, United States

    Description

    Microscan plus Negative Combo 3 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.

    Reason

    Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.

    Code Info

    Internal Number - B1016-201; Catalog Number - 10444600

    Distribution

    Worldwide Distribution - USA Nationwide in the states of: AK, SC, IA, MO GA, WI, TX, KS, CA, IL, CO, AZ, SD, IN, MD, FL, MN and the countries of:Japan, France, Algeria, Germany, Austria, Romania, Russian Federation, South Africa, Kazakhstan, Belgium, Great Britain, Turkey, Spain, Italy, Saudi Arabia, Qutar, Poland, Iraq, Unite Arab Emrites, Algeria, Oman, Greece, Portugal, and Ireland.

    Quantity

    57,600 panels in total