BEUDAMED
    FDA Recall Terminated

    ADVIA Chemistry Calibrator

    Recall: Z-2430-2020 · Initiated June 5, 2020

    Recall

    Recall Number
    Z-2430-2020
    Event Number
    85844
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2432235
    Product Code
    NDW
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 5, 2020
    Terminated
    November 18, 2021
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005

    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.

    Action

    Siemens Healthcare Diagnostics sent a letter notification sent to customers dated June 10, 2020. As one of the short-term alternatives for customers, where regulations permit, Siemens has evaluated the use of the lyophilized RANDOX Calibration Serum Level 3 Lot 1024UE. (CAL 3) for generating DBIL_2/DBil_2 and TBIL_2/TBil_2 results until a new lot of unaffected Siemens Chemistry Calibrator is available.

    Distribution

    US Nationwide Distribution

    Quantity

    1872 units