BEUDAMED
    FDA Enforcement Class II Terminated

    Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533

    Recall: Z-1231-2020 · Reported February 26, 2020

    Enforcement

    Recall Number
    Z-1231-2020
    Event ID
    84612
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 26, 2020
    Initiation Date
    December 18, 2019
    Classification Date
    February 14, 2020
    Termination Date
    June 25, 2020
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005, United States

    Description

    Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533

    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.

    Code Info

    UDI Number: 00630414595795 Lots: All lots

    Distribution

    US Nationwide

    Quantity

    824 units