BEUDAMED
    FDA Enforcement Class II Terminated

    MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 51, Catalog B1017-407 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.

    Recall: Z-1530-2015 · Reported May 6, 2015

    Enforcement

    Recall Number
    Z-1530-2015
    Event ID
    70893
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beckman Coulter, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 6, 2015
    Initiation Date
    August 8, 2014
    Classification Date
    April 27, 2015
    Termination Date
    April 27, 2015
    Address
    2040 Enterprise Blvd, West Sacramento, CA, 95691-3427, United States

    Description

    MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 51, Catalog B1017-407 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.

    Reason

    Technical Support Bulletin issued in February 2013 did not mention performance limitation for Proteus mirabilis and Imp when using the CLSIM100-S20 revised interpretive criteria.

    Code Info

    Catalog number: B1017-407; Siemens Material Number (SMN): 110444701.

    Distribution

    Worldwide Distribution: US (Nationwide) and to countries of: Argentina, Bahamas, Brazil, Canada, China, Ecuador, Egypt, Germany, Lithuania, Mexico, Paraguay, Peru Poland, Portugal, Romania, Russian Federation, Singapore, South Africa, Spain, Taiwan, Thailand, Trinidad and Tobago, United Arab Emirates, Uruguay, and Venezuela.

    Quantity

    Approx ~(216240 boxes U.S. and 84249 boxes OUS) total