BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0104-2023 · Initiated September 19, 2022

    Recall

    Recall Number
    Z-0104-2023
    Event Number
    90900
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2432235
    Product Code
    NDW
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    September 19, 2022
    Posted
    October 20, 2022
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005

    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.

    Action

    On September 19, 2022, the firm issued an Urgent Medical Device Correction letter to affected customers. Customers should take the following actions: -Please review this letter with your Medical Director. -Discontinue use of and discard the affected product. Siemens is temporarily discontinuing production and distribution of the Atellica CH lithium reagents until the issue is resolved. In the interim, Siemens is recommending that customers transition to an alternate lithium assay.

    Distribution

    Worldwide distribution - US Nationwide.

    Quantity

    1342 US; 2266 OUS