BEUDAMED
    FDA Enforcement Class II Ongoing

    Parvovirus B19 IgG EIA kit Part No. V519IGUS

    Recall: Z-2936-2020 · Reported September 9, 2020

    Enforcement

    Recall Number
    Z-2936-2020
    Event ID
    86152
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Diasorin Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 9, 2020
    Initiation Date
    July 17, 2020
    Classification Date
    September 3, 2020
    Address
    1951 Northwestern Ave S, N/A, Stillwater, MN, 55082-7536, United States

    Description

    Parvovirus B19 IgG EIA kit Part No. V519IGUS

    Reason

    Printed label inside the box lid of the Parvovirus has the incorrect Lot Specific Constant value

    Code Info

    Lot 71440040AA

    Distribution

    NJ, WI, NY, NC, MN, CA, IL, VA, MA, MI, CT Canada

    Quantity

    615 units