BEUDAMED
    FDA Recall 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 · Initiated June 11, 2014

    Recall

    Recall Number
    Z-2057-2014
    Event Number
    68583
    Firm
    Remel Inc
    FEI Number
    1924669
    Product Code
    MDB
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    June 11, 2014
    Posted
    July 15, 2014
    Terminated
    August 28, 2014
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519

    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.

    Action

    The recalling firm made phone calls to their customers beginning 6/11/14 with follow-up letters dated 6/12/14 being issued via regular mail requesting the affected product be destroyed. Additional customers were later identified and additional phone calls were made on 6/16/14 and recall letters dated 6/16/14 were issued via regular mail.

    Distribution

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

    Quantity

    76/50-bottle boxes