BEUDAMED
    FDA Recall Terminated

    Microscan plus Negative Breakpoint Combo 4 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-2126-2013 · Initiated August 21, 2013

    Recall

    Recall Number
    Z-2126-2013
    Event Number
    66058
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2919016
    Product Code
    LON
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 21, 2013
    Posted
    September 11, 2013
    Terminated
    May 15, 2014
    Address
    2040 Enterprise Blvd, West Sacramento, CA, 95691-3427

    Description

    Microscan plus Negative Breakpoint Combo 4 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.

    Action

    Siemens sent an Urgent Field Safety Notice letters dated August 2013 to all US customers via over night delivery, receipt requested. Letters for foreign customers are being translated and will be sent as soon as possible. The letter identified the affected product, reason for field correction, risk to health problem and actions to be taken by customer. Customers were instructed to suppress all reporting of sensitive and intermediate results for imipenem and meropenem. Siemens also recommends that the customer consider the need to review previous test results, conduct patient follow-up, and/or repeat testing. Customer were requested to complete the attached Field Correction Effectiveness Check form and fax it to 302-631-8467. For questions contact your Siemens Technical Support Provider or Distributor.

    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