BEUDAMED
    FDA Recall Terminated

    EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4006

    Recall: Z-0315-06 · Initiated October 14, 2005

    Recall

    Recall Number
    Z-0315-06
    Event Number
    33957
    Firm
    Dakocytomation California Inc
    FEI Number
    2022180
    Product Code
    NJT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 14, 2005
    Posted
    December 23, 2005
    Terminated
    January 29, 2007
    Address
    6392 Via Real, Carpinteria, CA, 93013-2921

    Description

    EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4006

    Reason

    This recall has been initiated due to a formulation error in the EnVision+ visualization reagent.

    Action

    Notification letter dated October 14, 2005 was sent by certified mail to cosignees instructing dosposal of product.

    Distribution

    Nationwide to: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, and WV. Worldwide to: Argentina, Bermuda, Brazil, Canada, Costa Rica, Denmark, Japan, Mexico, New Zealand, and Uruguay.

    Quantity

    Lots 045172=199 & 075112=112