BEUDAMED
    FDA Recall 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 · Initiated October 10, 2012

    Recall

    Recall Number
    Z-0801-2013
    Event Number
    63584
    Firm
    Remel Inc
    FEI Number
    1924669
    Product Code
    JSK
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    October 10, 2012
    Posted
    February 11, 2013
    Terminated
    June 4, 2013
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519

    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.

    Action

    ThermoFisher Scientific notified customers on October 10, 2012, with a Field Safety Notice letter to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised use of this lot could result in incorrect results reporting. This notice needs to be passed on to all who need to be aware within your organization. The firm request the information form be faxed back confirming receipt of notice. For further information please contact Technical Support via our main switchboard on +44 (0) 1256 841144.

    Distribution

    Distribution included the states of IL, IN and MI.

    Quantity

    10 units