BEUDAMED
    FDA Recall Terminated

    Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2

    Recall: Z-1274-2021 · Initiated February 8, 2021

    Recall

    Recall Number
    Z-1274-2021
    Event Number
    87381
    Firm
    Siemens Healthcare Diagnostics, Inc
    FEI Number
    1219913
    Product Code
    MYF
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    February 8, 2021
    Posted
    March 18, 2021
    Terminated
    February 7, 2025
    Address
    333 Coney St, East Walpole, MA, 02032-1516

    Description

    Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2

    Reason

    Potential false positive HSV results. Siemens Healthcare Diagnostics, Inc. initiated a correction for ADVIA Centaur4P Herpes-2 lgG (HSV2) Onboard Stability and Calibration Frequency (Interval) Failures on the ADVIA Centaur XP System and ADVIA Centaur XPT System.

    Action

    In February 2021, Siemens will issue an Urgent Medical Device Correction notice to customers via letter stating that Siemens Healthcare Diagnostics Inc. has confirmed that the ADVIA Centaur HSV2 assay does not meet the 60 day onboard stability or the 28 day calibration frequency (interval) as stated in the ADVIA Centaur XP/XPT Herpes-2 IgG (HSV2).

    Distribution

    Domestic: AL, CA, FL, IL, MD, NJ, NY, TN, TX. Foreign: Nepal, Chile, Georgia, Spain.

    Quantity

    390 kits total (Domestic 366 kits, Foreign 24 kits)