BEUDAMED
    FDA Recall Terminated

    Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is being considered. BioGenex brand InSite HER-2/neu Monoclonal Antibody, Manual; Model number: AM134-5MP; Lot Numbers: AM134P1005

    Recall: Z-0608-06 · Initiated February 9, 2006

    Recall

    Recall Number
    Z-0608-06
    Event Number
    34586
    Firm
    Biogenex Laboratories
    FEI Number
    2936532
    Product Code
    MVC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 9, 2006
    Posted
    March 15, 2006
    Terminated
    August 23, 2006
    Address
    4600 Norris Canyon Rd, San Ramon, CA, 94583-1320

    Description

    Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is being considered. BioGenex brand InSite HER-2/neu Monoclonal Antibody, Manual; Model number: AM134-5MP; Lot Numbers: AM134P1005

    Reason

    Products produce granular staining in immunostained tissue sections, which may lead to misdiagnosis due to false positive result.

    Action

    On 2/9/06, the firm issued letters via UPS to all of its consignees, informing them of the affected products and providing instructions on the recall.

    Distribution

    Nationwide. Italy, and United Kingdom. The product was released for distribution to 21 consignees nationwide to CA, FL, GA, IA, IL, NC, NJ, NY, TX, VT, WA, and WI. One VA account: VA Medical Center, Gwen Levy, Bld. 500, Room 1238, 11301 Wilshire Blvd., Los Angeles, CA 90073. 2 overseas consignees distributed the product to Italy (Space Imports Export SPL, Via Ranzato, 12, 1-20128 Milano, Italy and United Kingdom (Launch Diagnosis, West Yoke Farm unit 11, Michaels, Lane, Sevenoaks, Kent, TN15 7EP United Kingdom

    Quantity

    1 unit