BEUDAMED
    FDA Recall Terminated

    BinaxNOW A&B Kit 10 Test Kit (Japan) Part No. 416-110J contains NP Swabs with '8995' labeled on the swab wrapper

    Recall: Z-0826-2007 · Initiated March 28, 2007

    Recall

    Recall Number
    Z-0826-2007
    Event Number
    37843
    Firm
    Binax, Inc. dba IMPD
    FEI Number
    1221359
    Product Code
    GNX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 28, 2007
    Posted
    May 23, 2007
    Terminated
    September 8, 2008
    Address
    10 Southgate Rd, Scarborough, ME, 04074-8303

    Description

    BinaxNOW A&B Kit 10 Test Kit (Japan) Part No. 416-110J contains NP Swabs with '8995' labeled on the swab wrapper

    Reason

    Tip of the foam swab could detach from the shaft causing injury to the patient.

    Action

    Inverness Medical issued recall notification by letter on 3/28/07. Customers are instructed to discard the NP swabs provided in the kits. The firm will replace the NP swabs. In the meantime customers are to use the tests with nasal wash/aspirate samples (influenza) or nasal wash samples (RSV). Response letters are to be signed by customers and returned to Inverness Medical.

    Distribution

    Nationwide and Japan.

    Quantity

    3814 kits