BEUDAMED
    FDA Enforcement Class III Terminated

    Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Product Usage: Used for the isolation of fungi from surfaces sanitized with quaternary ammonium compounds

    Recall: Z-2212-2017 · Reported June 7, 2017

    Enforcement

    Recall Number
    Z-2212-2017
    Event ID
    77281
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Acumedia Manufacturers, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 7, 2017
    Initiation Date
    August 8, 2016
    Classification Date
    June 1, 2017
    Termination Date
    June 2, 2017
    Address
    740 E Shiawassee St, Lansing, MI, 48912-1218, United States

    Description

    Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Product Usage: Used for the isolation of fungi from surfaces sanitized with quaternary ammonium compounds

    Reason

    Storage temperature listed on the label was incorrect. Label stated 2-30¿C. Actual storage temperature is 2-8¿C.

    Code Info

    PN 91081C, Lot 108367A PN 91081C, Lot 107632A

    Distribution

    US in the state of IL

    Quantity

    10 units