BEUDAMED
    FDA Enforcement Class II Ongoing

    Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637

    Recall: Z-0930-2022 · Reported April 20, 2022

    Enforcement

    Recall Number
    Z-0930-2022
    Event ID
    89740
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 20, 2022
    Initiation Date
    February 9, 2022
    Classification Date
    April 14, 2022
    Address
    511 Benedict Ave, N/A, Tarrytown, NY, 10591-5005, United States

    Description

    Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637

    Reason

    Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.

    Code Info

    UDI: 00630414595580; Lot Numbers: 211359 211451

    Distribution

    Global Distribution. US Nationwide.

    Quantity

    199