BEUDAMED
    FDA Recall 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 · Initiated August 8, 2016

    Recall

    Recall Number
    Z-2212-2017
    Event Number
    77281
    Firm
    Acumedia Manufacturers, Inc.
    FEI Number
    1120041
    Product Code
    JSG
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    August 8, 2016
    Posted
    June 1, 2017
    Terminated
    June 2, 2017
    Address
    740 E Shiawassee St, Lansing, MI, 48912-1218

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

    Action

    On 8/8/2016 and 10/6/2016, notifications were sent to the affected consignees via e-mail. The recall notification included a description of the reason for the recall, affected product, and information for the correction to product.

    Distribution

    US in the state of IL

    Quantity

    10 units