BEUDAMED
    FDA Recall Terminated

    ADVIA Centaur iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).

    Recall: Z-1512-2013 · Initiated May 14, 2013

    Recall

    Recall Number
    Z-1512-2013
    Event Number
    65224
    Firm
    Siemens Healthcare Diagnostics, Inc
    FEI Number
    1219913
    Product Code
    CEW
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    May 14, 2013
    Posted
    June 6, 2013
    Terminated
    March 5, 2015
    Address
    333 Coney St, East Walpole, MA, 02032-1516

    Description

    ADVIA Centaur iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).

    Reason

    iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability

    Action

    Siemens sent an Urgent Medical Device Correction letter dated May 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. For questions, contact your Siemens Technical Solutions Center or your local Siemens technical support.

    Distribution

    Nationwide Distribution.

    Quantity

    309 (100 test) kits