BEUDAMED
    FDA Recall Terminated

    Anti-CD45 Cocktail antibody in 6 ml vials; Cat. No. AM371-5M , manufactured and distributed by BioGenex, San Ramon, CA

    Recall: Z-1519-06 · Initiated September 5, 2006

    Recall

    Recall Number
    Z-1519-06
    Event Number
    36259
    Firm
    Biogenex Laboratories
    FEI Number
    2936532
    Product Code
    NJT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 5, 2006
    Posted
    September 23, 2006
    Terminated
    November 17, 2006
    Address
    4600 Norris Canyon Road, San Ramon, CA, 94583-1320

    Description

    Anti-CD45 Cocktail antibody in 6 ml vials; Cat. No. AM371-5M , manufactured and distributed by BioGenex, San Ramon, CA

    Reason

    Mislabeling: Anti-CD45 cocktail antibody mislabeled as Ki-67.

    Action

    On 9/5/06, the firm issued a notification letter to the consignees with a correct label to apply, and a return the reply form included with the letter.

    Distribution

    Worldwide distribution --- including state of Texas and countries of Amman, Jordan, and India.

    Quantity

    13 vials.