BEUDAMED
    FDA Recall Terminated

    D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vitro Diagnostic Use.: a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of O-linked sialoglyprotein protein by immunohistochemistry (ICH) in formalin fixed paraffin embedded human tissues.

    Recall: Z-1676-2015 · Initiated May 6, 2015

    Recall

    Recall Number
    Z-1676-2015
    Event Number
    71229
    Firm
    Biocare Medical, LLC
    FEI Number
    3004140393
    Product Code
    NJT
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    May 6, 2015
    Posted
    May 26, 2015
    Terminated
    June 4, 2015
    Address
    4040 Pike Ln, Concord, CA, 94520-1227

    Description

    D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vitro Diagnostic Use.: a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of O-linked sialoglyprotein protein by immunohistochemistry (ICH) in formalin fixed paraffin embedded human tissues.

    Reason

    Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40.

    Action

    Biocare Medical sent a Medical Device Notification letter dated May 6, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete all actions listed on the enclosed Return Response Form.

    Distribution

    Worldwide Distribution - US Nationwide in the states of: MI, SC, NC, AZ, CA, MO, WI and Hungary, Spain and Austria.

    Quantity

    19 units