BEUDAMED
    FDA Enforcement Class III Terminated

    Nutrient Gelatin, Acumedia Part Number 7471 A Product Usage: Nutrient Gelatin is used for the differentiation of microorganisms on the basis of gelatinase production. Identifying fermentative and non-fermentative Gram-negative bacilli include testing for gelatin liquefaction. If the proteolytic enzyme gelatinase is present, gelatin is hydrolyzed and loses its gelling characteristic.

    Recall: Z-2213-2017 · Reported June 7, 2017

    Enforcement

    Recall Number
    Z-2213-2017
    Event ID
    77275
    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
    March 23, 2016
    Classification Date
    June 1, 2017
    Termination Date
    June 2, 2017
    Address
    740 E Shiawassee St, Lansing, MI, 48912-1218, United States

    Description

    Nutrient Gelatin, Acumedia Part Number 7471 A Product Usage: Nutrient Gelatin is used for the differentiation of microorganisms on the basis of gelatinase production. Identifying fermentative and non-fermentative Gram-negative bacilli include testing for gelatin liquefaction. If the proteolytic enzyme gelatinase is present, gelatin is hydrolyzed and loses its gelling characteristic.

    Reason

    Incorrect expiration date was listed on the label. Correct expiration date was November 30, 2016. Product was labeled with expiration date of April 30, 2018.

    Code Info

    PN 7471A, Lot 105550F

    Distribution

    Worldwide - US Nationwide in the state of ME; in the country of ECUADOR

    Quantity

    5 units