BEUDAMED
    FDA Enforcement Class II Ongoing

    N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299

    Recall: Z-0094-2023 · Reported October 26, 2022

    Enforcement

    Recall Number
    Z-0094-2023
    Event ID
    90867
    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
    August 30, 2022
    Classification Date
    October 14, 2022
    Address
    511 Benedict Ave, N/A, Tarrytown, N/A, N/A, Spain

    Description

    N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299

    Reason

    N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF).

    Code Info

    UDI-DI: 0405686900179VF Lot Number: 153083; 153085; 153087A; 153090; 153095B; 153099A; 153004B. Future lots may be impacted by the issue but will then be provided with a corresponding instruction note within the reagent package

    Distribution

    Nationwide

    Quantity

    10,201 packs