BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-2113-2014 · Reported July 30, 2014

    Enforcement

    Recall Number
    Z-2113-2014
    Event ID
    68709
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biogenex Laboratories, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    July 30, 2014
    Initiation Date
    July 1, 2014
    Classification Date
    July 24, 2014
    Termination Date
    July 24, 2014
    Address
    49026 Milmont Dr, Fremont, CA, 94538-7301, United States

    Description

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

    Reason

    Product was distributed without 510(k) approval.

    Code Info

    Catalog number RD471-60K: Lot numbers: RD4710111, Exp Jan 2012; RD4710411, Exp. Apr 2012; RD4711013, Exp Oct 2014.

    Distribution

    Brazil and Ecuador. No US distribution

    Quantity

    4 kits