BEUDAMED
    FDA Enforcement Class I Terminated

    Microscan Synergies Plus Negative Breakpoint Combo 7 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-2121-2013 · Reported September 18, 2013

    Enforcement

    Recall Number
    Z-2121-2013
    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 Synergies Plus Negative Breakpoint Combo 7 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 B1025-109, Catalog Number - 10444748 Lot code/expiration date: 2012-08-17, 2012-08-17; 2012-10-06, 2012-10-06; 2012-12-08, 2012-12-08; 2013-01-09, 2013-01-09; 2013-03-02, 2013-03-02; 2013-04-12, 2013-04-12; 2013-06-15, 2013-06-15; 2013-08-06, 2013-08-06; 2013-09-24, 2013-09-24; 2013-12-07, 2013-12-07; 2014-01-08, 2014-01-08; 2014-01-31, 2014-01-31; 2014-03-25, 2014-03-25; 2014-05-09, 2014-05-09; 2014-07-01, 2014-07-01.

    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

    4319 boxes, 86, 380 panels