BEUDAMED
    FDA Enforcement Class II Terminated

    The product is a lyophilized growth supplement for use with dehydrated culture media to prepare BCYE Medium used for isolation of Legionellae from clinical and environmental samples.

    Recall: Z-0801-2013 · Reported February 20, 2013

    Enforcement

    Recall Number
    Z-0801-2013
    Event ID
    63584
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Remel Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 20, 2013
    Initiation Date
    October 10, 2012
    Classification Date
    February 11, 2013
    Termination Date
    June 4, 2013
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519, United States

    Description

    The product is a lyophilized growth supplement for use with dehydrated culture media to prepare BCYE Medium used for isolation of Legionellae from clinical and environmental samples.

    Reason

    The product may contain low level microbial contamination which could result in incorrect results.

    Code Info

    Lot 1175209

    Distribution

    Distribution included the states of IL, IN and MI.

    Quantity

    10 units