BEUDAMED
    FDA Recall 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 · Initiated April 4, 2014

    Recall

    Recall Number
    Z-1536-2014
    Event Number
    67948
    Firm
    BD Biosciences, Systems & Reagents
    FEI Number
    2916837
    Product Code
    MVU
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 4, 2014
    Posted
    May 1, 2014
    Terminated
    September 28, 2015
    Address
    2350 Qume Dr, San Jose, CA, 95131-1812

    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.

    Action

    Customer product recall notification letters were sent to all consignees on April 4, 2014 by certified mail.

    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