BEUDAMED
    FDA Recall Terminated

    BioGenex brand Hepatitis B Virus Core Antigen Antibody, Cat. No. AR082-5R and PU082-UP, Product is distributed by BioGenex Laboratories, 4600 Norris Canyon Rd., San Ramon, CA 94583

    Recall: Z-1438-06 · Initiated June 2, 2006

    Recall

    Recall Number
    Z-1438-06
    Event Number
    35614
    Firm
    Biogenex Laboratories
    FEI Number
    2936532
    Product Code
    MVU
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 2, 2006
    Posted
    August 29, 2006
    Terminated
    November 17, 2006
    Address
    4600 Norris Canyon Road, San Ramon, CA, 94583-1320

    Description

    BioGenex brand Hepatitis B Virus Core Antigen Antibody, Cat. No. AR082-5R and PU082-UP, Product is distributed by BioGenex Laboratories, 4600 Norris Canyon Rd., San Ramon, CA 94583

    Reason

    Misbranding-The product labeling (label and insert) is misbranded in that the product does not comply with the labeling requirements for an Analyte Specific Reagent (ASR).

    Action

    On 6/5/06, via letter explaining the reason for the recall and requesting the product be disposed.

    Distribution

    Nationwide

    Quantity

    96 units for both Recalls Z-1438/1439-06