BEUDAMED
    FDA Recall Terminated

    ADVIA Centaur (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.

    Recall: Z-0859-2015 · Initiated October 9, 2014

    Recall

    Recall Number
    Z-0859-2015
    Event Number
    69582
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2432235
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 9, 2014
    Posted
    December 23, 2014
    Terminated
    March 16, 2017
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005

    Description

    ADVIA Centaur (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.

    Reason

    A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress.

    Action

    A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress.

    Distribution

    Nationwide Distribution including PR and the states of AK, AL, AR, AZ, CA, CO, CT, MD, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.

    Quantity

    10,515 units total