BEUDAMED
    FDA Enforcement Class II Terminated

    Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438), a liquid tissue culture supernatant. For in vitro diagnostic use.

    Recall: Z-1698-2014 · Reported June 11, 2014

    Enforcement

    Recall Number
    Z-1698-2014
    Event ID
    68065
    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
    February 26, 2014
    Classification Date
    June 2, 2014
    Termination Date
    August 14, 2017
    Address
    1700 Leider Ln, Buffalo Grove, IL, 60089-6622, United States

    Description

    Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438), a liquid tissue culture supernatant. For in vitro diagnostic use.

    Reason

    Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (Product Code: NCL-L-GSTpi-438) does not function as intended up to the expiry date on the product labeling. This was detected through an ongoing stability program. There is a linkage between the age of the product and staining intensity.

    Code Info

    Product Code: NCL-L-GSTpi-438; Lot Numbers and Expiration Dates: 6018777, Expires 2014-05; 6023260, Expires 2014-12; 6026297, Expires 2015-05; 6026980, Expires 2015-06

    Distribution

    Nationwide Distribution including AZ, CA, FL, and NY.

    Quantity

    33 units