BEUDAMED
    FDA Enforcement Class II Terminated

    Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test.

    Recall: Z-0957-2013 · Reported March 27, 2013

    Enforcement

    Recall Number
    Z-0957-2013
    Event ID
    63767
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 27, 2013
    Initiation Date
    November 27, 2012
    Classification Date
    March 15, 2013
    Termination Date
    August 4, 2014
    Address
    500 GBC Drive, Mailstop 514, PO BOX 6101, Newark, DE, 19714-6101, United States

    Description

    Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test.

    Reason

    Siemens has confirmed customer complaints of low patient sample recovery with Dimension(R) TACR Flex(R) lot FA3085. Quality Control (QC) materials have not exhibited low recovery of the same magnitude. Internal method regression testing versus LC/MS has shown an average 25% low bias compared to LC/MS across the assay range. Individual patients, particularly samples with lower TACR values

    Code Info

    Lot numbers FA3085, exp 2013-03-26; and FA3316, exp 2013-11-12

    Distribution

    Product was distributed within the United States to AL, AZ, CA, DC, FL, LA, MD, MI, MO, NJ, NM, NC, OH, OR, PA, TN, TX, UT, VA, and WA.

    Quantity

    2,976