BEUDAMED
    FDA Enforcement Class II Terminated

    ADVIA Chemistry Calibrator

    Recall: Z-2430-2020 · Reported July 1, 2020

    Enforcement

    Recall Number
    Z-2430-2020
    Event ID
    85844
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 1, 2020
    Initiation Date
    June 5, 2020
    Classification Date
    June 26, 2020
    Termination Date
    November 18, 2021
    Address
    511 Benedict Ave, N/A, Tarrytown, NY, 10591-5005, United States

    Description

    ADVIA Chemistry Calibrator

    Reason

    Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry Calibrator lot 534177 for ADVIA Chemistry and lot 534179 for Atellica CH.

    Code Info

    Lots: 534177 (including sublots A, B and C) 960742 UDI: (01)00630414223414(10)534177(17)20210930 (01)00630414223414(10)534177A(17)20211031 (01)00630414223414(10)534177B(17)20211231 (01)00630414223414(10)534177C(17)20220131 (01)00630414223414(10)534177D(17)20220331 (01)00630414223414(10)960742(17)20220531

    Distribution

    US Nationwide Distribution

    Quantity

    1872 units