BEUDAMED
    FDA Recall 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 · Initiated November 27, 2012

    Recall

    Recall Number
    Z-0957-2013
    Event Number
    63767
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    MLM
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 27, 2012
    Posted
    March 15, 2013
    Terminated
    August 4, 2014
    Address
    500 GBC Drive PO BOX 6101, Mailstop 514, Newark, DE, 19714-6101

    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

    Action

    The firm initiated their recall of this product on November 27, 2012 by sending a letter to all consignees. The letter included a recall effectiveness check form to be completed by the consignee and returned to the firm. The firm expanded their recall on January 29, 2013 by sending another letter to consignees. This letter also included a recall effectiveness check form to be completed by the consignee and returned to the firm.

    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