BEUDAMED
    FDA Enforcement Class II Terminated

    Vulcan Fast Red Chromogen Kit 2, part of an immunohistochemistry (IHC) procedure using an alkaline phosphatase (AP) detection system. Catalog numbers FR805-5L and FR805S

    Recall: Z-2360-2018 · Reported July 11, 2018

    Enforcement

    Recall Number
    Z-2360-2018
    Event ID
    80322
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biocare Medical, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 11, 2018
    Initiation Date
    April 24, 2018
    Classification Date
    July 5, 2018
    Termination Date
    July 14, 2020
    Address
    60 Berry Dr, Pacheco, CA, 94553-5601, United States

    Description

    Vulcan Fast Red Chromogen Kit 2, part of an immunohistochemistry (IHC) procedure using an alkaline phosphatase (AP) detection system. Catalog numbers FR805-5L and FR805S

    Reason

    Chromogen failed to develop due to a stability issue caused by environmental factors with a raw material in the Vulcan Fast Red Buffer.

    Code Info

    Lot numbers 011818 and 022818

    Distribution

    CA, VT, KY, LA, OR, RI, GA, IL, MA, TX, KS, FL, Japan, and Germany

    Quantity

    43 units