BEUDAMED
    FDA Enforcement Class III Terminated

    Plastic bottle containing 10.5 mL of IgG Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits

    Recall: Z-1477-2013 · Reported June 12, 2013

    Enforcement

    Recall Number
    Z-1477-2013
    Event ID
    64164
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bion Enterprises Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 12, 2013
    Initiation Date
    January 23, 2013
    Classification Date
    June 5, 2013
    Termination Date
    May 5, 2015
    Address
    455 State St, Suite 100, Des Plaines, IL, 60016-2204, United States

    Description

    Plastic bottle containing 10.5 mL of IgG Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits

    Reason

    Affected products have a labeled expiration date of one year too long.

    Code Info

    Product Code: CCG-9912; Lot: CCG-0280

    Distribution

    Worldwide Distribution - United States (nationwide) in the states of IN, SC and the countries of Canada (Toronto); South Africa (Randburg) and Brazil (Rio de Janeiro)

    Quantity

    207 units