BEUDAMED
    FDA Enforcement Class II Terminated

    EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments.

    Recall: Z-2330-2016 · Reported August 10, 2016

    Enforcement

    Recall Number
    Z-2330-2016
    Event ID
    74608
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Dako Denmark A/S
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 10, 2016
    Initiation Date
    July 6, 2016
    Classification Date
    August 3, 2016
    Termination Date
    October 13, 2016
    Address
    Produktionsvej 42, Glostrup, N/A, Denmark

    Description

    EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments.

    Reason

    The pH of Target Retrieval Solution in the kit measures 4-5 instead of the correct pH of 9.1.

    Code Info

    K8002 Lot no: 10112879 K8004 Lot no: 10111463

    Distribution

    Worldwide Distribution -- US, Canada, and Colombia.

    Quantity

    147 kits