BEUDAMED
    FDA Recall Terminated

    Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.

    Recall: Z-1587-2018 · Initiated February 26, 2018

    Recall

    Recall Number
    Z-1587-2018
    Event Number
    79683
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2432235
    Product Code
    JGS
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 26, 2018
    Terminated
    May 12, 2020
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005

    Description

    Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.

    Reason

    When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers

    Action

    Recall initiated 02/23/2018 Firm released an update software (SW) version (V), 1.12.1, which corrects the behavior. A Mandatory Update (MU) campaign was launched to install the new SW V on all systems, whether or not they are impacted by this behavior. The MU campaign will be tracked to 100% completion globally.

    Distribution

    FL and France Spain Sweden United Kingdom Germany