BEUDAMED
    FDA Recall Terminated

    Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System, Catalog number AS4010B

    Recall: Z-1471-2008 · Initiated January 24, 2008

    Recall

    Recall Number
    Z-1471-2008
    Event Number
    46903
    Firm
    Biogenex Laboratories
    FEI Number
    2936532
    Product Code
    KEY
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    January 24, 2008
    Posted
    August 22, 2008
    Terminated
    January 8, 2011
    Address
    4600 Norris Canyon Road, San Ramon, CA, 94583-1320

    Description

    Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System, Catalog number AS4010B

    Reason

    Bulk reagent dispensing mechanism may break resulting in reagent spill and possible exposure to chemicals.

    Action

    The firm initiated written notification on 01/24/2008. The firm has asked its consignee to inform its consignees of the recall.

    Distribution

    Product was distributed to a single distributor, which further distributed the product.

    Quantity

    10 units distributed.