BEUDAMED
    FDA Recall Terminated

    Remel RapID Inoculation Fluid, Microorganism differentiation and identification device, Packaged in 1-ml tube, Catalog Number: R8325102, 20/pack, Remel, Lenexa, KS 66215

    Recall: Z-1624-2008 · Initiated October 23, 2007

    Recall

    Recall Number
    Z-1624-2008
    Event Number
    46801
    Firm
    Remel Inc
    FEI Number
    1924669
    Product Code
    LIB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 23, 2007
    Posted
    May 14, 2008
    Terminated
    July 16, 2008
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215

    Description

    Remel RapID Inoculation Fluid, Microorganism differentiation and identification device, Packaged in 1-ml tube, Catalog Number: R8325102, 20/pack, Remel, Lenexa, KS 66215

    Reason

    Failure to produce reaction: Use of the product with various RapID Identification systems panels may exhibit poor or no reactions.

    Action

    Consignees were notified by an Important Medical Device Customer Advisory Notice on 10/23/07. The letter instructs users to review inventory and discard any affected products. The letter also instructs users to return a product inventory checklist by 11/23/07. For additional information, contact 1-800-447-3641.

    Distribution

    Worldwide Distribution including USA and countries of Taiwan, Japan, and U.K.

    Quantity

    500/1-ml packs