BEUDAMED
    FDA Recall Terminated

    Remel Chocolate Agar, catalog #01301, containing 15 plates/pkg, for in-vitro diagnostic use. The firm name on the label is Remel, Lenexa, KS.

    Recall: Z-0024-05 · Initiated September 27, 2004

    Recall

    Recall Number
    Z-0024-05
    Event Number
    30154
    Firm
    Remel, Inc.
    FEI Number
    1924669
    Product Code
    KZI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 27, 2004
    Posted
    October 20, 2004
    Terminated
    April 25, 2006
    Address
    12076 Santa Fe Trail Dr (PO Box 14478, zip 66285-4478), Lenexa, KS, 66215-3519

    Description

    Remel Chocolate Agar, catalog #01301, containing 15 plates/pkg, for in-vitro diagnostic use. The firm name on the label is Remel, Lenexa, KS.

    Reason

    The product does not perform as intended with some quality control organisms (Haemophilus influenzae)

    Action

    The recalling firm notified their customers via telephone on 9/27/04 requesting they examine their inventory and discard the recalled lot.

    Distribution

    Distribution was made to medical facilities and laboratories located in IA, KS, MO, FL, NY, IL, AR, TX, and OK.

    Quantity

    4,620 units (308 packages)