BEUDAMED
    FDA Recall 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 · Initiated April 24, 2018

    Recall

    Recall Number
    Z-2360-2018
    Event Number
    80322
    Firm
    Biocare Medical, LLC
    FEI Number
    3004140393
    Product Code
    NJT
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    April 24, 2018
    Terminated
    July 14, 2020
    Address
    60 Berry Dr, Pacheco, CA, 94553-5601

    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.

    Action

    On April 24, 2018 the recalling firm issued a notification letter to their customers with instructions to return a response form.

    Distribution

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

    Quantity

    43 units