BEUDAMED
    FDA Recall Terminated

    ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869

    Recall: Z-1230-2020 · Initiated December 18, 2019

    Recall

    Recall Number
    Z-1230-2020
    Event Number
    84612
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2432235
    Product Code
    JFY
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 18, 2019
    Posted
    January 24, 2020
    Terminated
    June 25, 2020
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005

    Description

    ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869

    Reason

    There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology.

    Action

    Siemens Healthcare Diagnostics initiated a customer communication for this issue via letter beginning December 18, 2019.

    Distribution

    US Nationwide

    Quantity

    1,015 units