BEUDAMED
    FDA Recall Terminated

    Plastic bottle containing 3.5 mL of IgG FITC Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits

    Recall: Z-1479-2013 · Initiated January 23, 2013

    Recall

    Recall Number
    Z-1479-2013
    Event Number
    64164
    Firm
    Bion Enterprises Ltd
    FEI Number
    1419968
    Product Code
    LJY
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    January 23, 2013
    Posted
    June 5, 2013
    Terminated
    May 5, 2015
    Address
    455 State St, Suite 100, Des Plaines, IL, 60016-2204

    Description

    Plastic bottle containing 3.5 mL of IgG FITC Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits

    Reason

    Affected products have a labeled expiration date of one year too long.

    Action

    MBL Bion sent an Urgent Product Recall letter dated January 28, 2013 to all affected customers via email. The letter identified the affected product, problem and actions to be taken. Customers were requested to destroy the affected product and to notify Bion of the number of units consumed and destroyed. For questions call 847-544-5044.

    Distribution

    Worldwide Distribution - United States (nationwide) in the states of IN, SC and the countries of Canada (Toronto); South Africa (Randburg) and Brazil (Rio de Janeiro)

    Quantity

    504 units