BEUDAMED
    FDA Enforcement Class II Terminated

    Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture supernatant containing 15 mM sodium azide as a preservative. For in vitro diagnostic use.

    Recall: Z-1710-2014 · Reported June 11, 2014

    Enforcement

    Recall Number
    Z-1710-2014
    Event ID
    68090
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Leica Microsystems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 11, 2014
    Initiation Date
    January 10, 2014
    Classification Date
    June 3, 2014
    Termination Date
    September 5, 2017
    Address
    1700 Leider Ln, Buffalo Grove, IL, 60089-6622, United States

    Description

    Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture supernatant containing 15 mM sodium azide as a preservative. For in vitro diagnostic use.

    Reason

    Product does not function as intended up to the expiry date on the product labeling. There is a link between the age of the product and staining intensity.

    Code Info

    Product Code: NCL-L-CD15; Lot Numbers and Expiration Dates: 6017936, Expires 2014-08; 6015073, Expires 2014-03

    Distribution

    Worldwide Distribution - US Nationwide in the states of CA, CT FL, IL, MO, MS, NC, NY, PA, and the countries of Argentina, Australia, Brazil, Colombia, Italy, Malaysia, New Zealand, Nigeria, Poland, Romania, Russia, Saudi Arabia, Serbia, South Africa, Sweden, Taiwan, Tunisia, Turkey, and United Kingdom

    Quantity

    145 units