BEUDAMED
    FDA Recall Terminated

    Stratus(R) CS Rotors, catalog number CROTOR, lot number NH42-251-09 Intended use: Stratus(R) rotors is intended for the separation of whole blood samples for analysis on the Stratus(R) CS analyzer

    Recall: Z-0343-2011 · Initiated December 7, 2009

    Recall

    Recall Number
    Z-0343-2011
    Event Number
    56976
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    JHX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 7, 2009
    Posted
    November 10, 2010
    Terminated
    November 10, 2010
    Address
    500 GBC Drive PO BOX 6101, Mailstop 514, Newark, DE, 19714-6101

    Description

    Stratus(R) CS Rotors, catalog number CROTOR, lot number NH42-251-09 Intended use: Stratus(R) rotors is intended for the separation of whole blood samples for analysis on the Stratus(R) CS analyzer

    Reason

    Low frequency defect in the gel filling of this lot that may result in inadequate separation of cells in centrifugation.

    Action

    The recalling firm, SIEMENS, issued an "Urgent Field Safety Notice" dated December 2009 to all affected customers. The notice described the product, problem and the action to be taken by the customers. The customers were instructed to review the situation with their laboratory director to determine the need to evaluate previously reported test results; immediately examine their CROTOR inventory and discard all bags that are from lot NH42-251-09 including rotors that were not stored in their original packaging (bag); contact Siemens Customer Service Center at 800-241-0420 to request additional no-charge replacements (Note: A "no-charge" order has already been placed so that one bag of replacement rotors would be recieved shortly); forward this notice to anyone they may have distributed this product, and complete and return the FIELD CORRECTION EFFECTIVENESS CHECK via fax at 302-631-8467. If you have any questions regarding this information, please contact the Siemens Technical Solution Center at 800-405-6473.

    Distribution

    Worldwide distribution: USA including states of AK, AZ, AR, CA, FL, GA, HI, IA, IL, IN, KY, LA, MI, MN, MO, MS, MT, NC, ND, NH, NM, NY, OH, TX, UT, WA, WI, and WV and country of Canada

    Quantity

    330 bags