BEUDAMED
    FDA Enforcement Class II Terminated

    Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. Intended for the qualitative identification by light microscopy of human calretinin molecule in paraffin sections.

    Recall: Z-1704-2016 · Reported June 1, 2016

    Enforcement

    Recall Number
    Z-1704-2016
    Event ID
    73823
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Leica Microsystems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 1, 2016
    Initiation Date
    March 22, 2016
    Classification Date
    May 20, 2016
    Termination Date
    November 30, 2017
    Address
    1700 Leider Ln, N/A, Buffalo Grove, IL, 60089-6622, United States

    Description

    Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. Intended for the qualitative identification by light microscopy of human calretinin molecule in paraffin sections.

    Reason

    Novocastra Liquid Mouse Monoclonal Antibody Calretinin when used in combination with specific Lots of antibody diluent will give reduced staining.

    Code Info

    Lot numbers: 6025204, 6029060, 6029949, 6035923 and 6036060.

    Distribution

    Worldwide Distribution -- U.S., to the following states: AK, CA, FL, GA, MN, MT, NJ, OH, TX and WA; and, the country of Canada.

    Quantity

    290 units