BEUDAMED
    FDA Recall Terminated

    InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.

    Recall: Z-2113-2014 · Initiated July 1, 2014

    Recall

    Recall Number
    Z-2113-2014
    Event Number
    68709
    Firm
    Biogenex Laboratories, Inc.
    FEI Number
    2936532
    Product Code
    MVC
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    July 1, 2014
    Posted
    July 24, 2014
    Terminated
    July 24, 2014
    Address
    49026 Milmont Dr, Fremont, CA, 94538-7301

    Description

    InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.

    Reason

    Product was distributed without 510(k) approval.

    Action

    Each customer contacted by phone - neither is in possession of the product.

    Distribution

    Brazil and Ecuador. No US distribution

    Quantity

    4 kits