BEUDAMED
    FDA Enforcement Class II Ongoing

    Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay

    Recall: Z-0104-2023 · Reported October 26, 2022

    Enforcement

    Recall Number
    Z-0104-2023
    Event ID
    90900
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 26, 2022
    Initiation Date
    September 19, 2022
    Classification Date
    October 20, 2022
    Address
    511 Benedict Ave, N/A, Tarrytown, NY, 10591-5005, United States

    Description

    Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay

    Reason

    Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the worst case, there is a potential for erroneously elevated lithium patient results, which may lead to inappropriate dosage adjustment, potentially affecting treatment efficacy.

    Code Info

    UDI-DI: 00630414287935 All lots impacted: Lots 110238 exp 10/18/22 110302 exp 12/13/22 120017 exp 4/18/23

    Distribution

    Worldwide distribution - US Nationwide.

    Quantity

    1342 US; 2266 OUS