BEUDAMED
    FDA Enforcement Class II Terminated

    Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against human epithelial adhesion molecule that has been identified as a 40 -kilodalton (kd) protein in Western Blotting.

    Recall: Z-1536-2014 · Reported May 7, 2014

    Enforcement

    Recall Number
    Z-1536-2014
    Event ID
    67948
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BD Biosciences, Systems & Reagents
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 7, 2014
    Initiation Date
    April 4, 2014
    Classification Date
    May 1, 2014
    Termination Date
    September 28, 2015
    Address
    2350 Qume Dr, San Jose, CA, 95131-1812, United States

    Description

    Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against human epithelial adhesion molecule that has been identified as a 40 -kilodalton (kd) protein in Western Blotting.

    Reason

    Two lots of Anti EpCAM PE-Analyte Specific Reagent are mislabeled - the actual antibody present in the vial is CD9 PE.

    Code Info

    Catalog number 347211; Lot number 3295974 - expiry date 2015-09-30; Lot number 3259822 - expiry date 2015-09-30.

    Distribution

    Worldwide Distribution-USA including the states of CA, TX, FL, MO, NY, MI, MO, and AZ and Seoul, Korea.

    Quantity

    12 for lot 3295974; 10 of lot 3259822