BEUDAMED
    FDA Enforcement Class II Terminated

    Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bottles/box, IVD. The firm name on the label is Remel Inc., Lenexa, KS.

    Recall: Z-2057-2014 · Reported July 23, 2014

    Enforcement

    Recall Number
    Z-2057-2014
    Event ID
    68583
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Remel Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    July 23, 2014
    Initiation Date
    June 11, 2014
    Classification Date
    July 15, 2014
    Termination Date
    August 28, 2014
    Address
    12076 Santa Fe Trail Dr, N/A, Lenexa, KS, 66215-3519, United States

    Description

    Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bottles/box, IVD. The firm name on the label is Remel Inc., Lenexa, KS.

    Reason

    Bottles did not provide positive signals within the time frame of the quality control specification for one of two strains of Streptococcus pneumoniae.

    Code Info

    Segments 1, 5, and 6 only of Lot 492571, Exp. 2015-10

    Distribution

    Distribution was made to CO, IL, IN, NE, NJ, PA, SD, and a government facility located in VA.

    Quantity

    76/50-bottle boxes