BEUDAMED
    FDA Recall Terminated

    Remel MacConkey Agar w/Sorbitol, growth medium, Catalog R01556, packaged 10/box. The firm name on the label is Remel, Lenexa, KS.

    Recall: Z-0621-2007 · Initiated February 21, 2007

    Recall

    Recall Number
    Z-0621-2007
    Event Number
    37423
    Firm
    Remel, Inc.
    FEI Number
    1924669
    Product Code
    JSI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 21, 2007
    Posted
    March 14, 2007
    Terminated
    March 6, 2008
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215

    Description

    Remel MacConkey Agar w/Sorbitol, growth medium, Catalog R01556, packaged 10/box. The firm name on the label is Remel, Lenexa, KS.

    Reason

    False negative results for sorbitol fermenting bacteria such as E. Coli 0157.

    Action

    Recall letters dated 2/19/07 were issued on 2/21/07 via regular mail explaining the reason for recall and requesting all remaining inventory of the affected lot be discarded. A Product Inventory Checklist was enclosed to indicate the amount of inventory the customer discarded. This was to be returned via FAX or mail in the return envelope provided.

    Distribution

    Nationwide.

    Quantity

    694/10-pack boxes