BEUDAMED
    FDA Recall Terminated

    Dryspot (R) Staphytect Plus, Catalog #DR0100M, 120 tests/kit. Latex slide agglutination test for the differentiation of Staphylococcus aureus by detection of clumping factor, Protein A and certain polysaccharides found in methicillin-resistant S. aureus (MRSA) from those staphylococci that do not possess these properties.

    Recall: Z-1008-2009 · Initiated October 7, 2008

    Recall

    Recall Number
    Z-1008-2009
    Event Number
    50224
    Firm
    Remel, Inc
    FEI Number
    1924669
    Product Code
    JWX
    Status
    Terminated
    Root Cause
    Pending
    Initiated
    October 7, 2008
    Posted
    March 20, 2009
    Terminated
    July 30, 2009
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519

    Description

    Dryspot (R) Staphytect Plus, Catalog #DR0100M, 120 tests/kit. Latex slide agglutination test for the differentiation of Staphylococcus aureus by detection of clumping factor, Protein A and certain polysaccharides found in methicillin-resistant S. aureus (MRSA) from those staphylococci that do not possess these properties.

    Reason

    Control and test wells are reversed on some of the reaction cards.

    Action

    The recalling firm issued Important Medical Device Customer Advisory Notice letters dated 10/7/08 via regular mail to their customers explaining the reason for recall. The letter requested that they review their inventory for the product lots indicated in the letter; discard all of the lot remaining in their inventory; complete and return the Product Inventory Checklist.

    Distribution

    Nationwide Distribution -- including MN, MI, IL, and NC.

    Quantity

    32 kits dist. by recalling firm