BEUDAMED
    FDA Recall Terminated

    Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System; Model Number/Catalog Number: AS4010B; The product is manufactured by: BioGenex Laboratories, Inc. 4600 Norris Canyon Road San Ramon, CA 94583 and Distributed by: Abbott Molecular, 1300 E. Touhy Ave - 2E, Des Plaines, IL 60018 Xmatrx Automated Staining System is intended for in vitro diagnostic use. It is suitable for fluorescent hybridization (FISH) applications.

    Recall: Z-1016-2010 · Initiated January 23, 2009

    Recall

    Recall Number
    Z-1016-2010
    Event Number
    51296
    Firm
    Biogenex Laboratories
    FEI Number
    2936532
    Product Code
    KEY
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 23, 2009
    Posted
    March 8, 2010
    Terminated
    December 2, 2010
    Address
    4600 Norris Canyon Road, San Ramon, CA, 94583-1320

    Description

    Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System; Model Number/Catalog Number: AS4010B; The product is manufactured by: BioGenex Laboratories, Inc. 4600 Norris Canyon Road San Ramon, CA 94583 and Distributed by: Abbott Molecular, 1300 E. Touhy Ave - 2E, Des Plaines, IL 60018 Xmatrx Automated Staining System is intended for in vitro diagnostic use. It is suitable for fluorescent hybridization (FISH) applications.

    Reason

    Under certain conditions, product system failure has the potential to cause operator injury due to splash of Hemo-De solution.

    Action

    On 1/23/09, the firm issued an Advisory Notice to all its direct consignees, informing them of the affected product and providing instructions on the recall. Please contact BioGenex Technical Support at 1-800-421-4149 for any assistance you may need.

    Distribution

    The firm distributed the product to one (1) distributor as a consignee of our product. The firm indicated that no customer has received the product directly from BioGenex, due to the fact that the product is exclusive distributed by Abbott Molecular.

    Quantity

    12 units