BEUDAMED
    FDA Recall 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 · Initiated September 25, 2016

    Recall

    Recall Number
    Z-2221-2017
    Event Number
    77276
    Firm
    Acumedia Manufacturers, Inc.
    FEI Number
    1120041
    Product Code
    JSI
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    September 25, 2016
    Terminated
    June 2, 2017
    Address
    740 E Shiawassee St, Lansing, MI, 48912-1218

    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 2-30C. Actual storage temperature is 2-8C.

    Action

    Neogen Corporation sent a Product Notification dated September 25, 2016, to all affected consignees via email. The recall notification included a description of the reason for the recall, affected product, and information for the correction to product. Consignees were informed that an internal corrective action has been initiated and actions have been taken and implemented to prevent this situation from occurring again. The label has been corrected and existing inventory has been relabeled. For questions regarding this recall call 800-234-5333, ext 2362.

    Distribution

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

    Quantity

    28 units