BEUDAMED
    FDA Enforcement Class III Terminated

    Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease production

    Recall: Z-2221-2017 · Reported June 14, 2017

    Enforcement

    Recall Number
    Z-2221-2017
    Event ID
    77276
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Acumedia Manufacturers, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 14, 2017
    Initiation Date
    September 25, 2016
    Classification Date
    June 2, 2017
    Termination Date
    June 2, 2017
    Address
    740 E Shiawassee St, N/A, Lansing, MI, 48912-1218, United States

    Description

    Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease production

    Reason

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

    Code Info

    PN 7226A, Lot 108812A PN 7226B, Lot 108812A PN 7226A, Lot 107 699C

    Distribution

    Worldwide Distribution - US to AZ; Internationally to ECUADOR; CANADA; UK; BRAZIL

    Quantity

    28 units