BEUDAMED
    FDA Recall Terminated

    Oxoid dry Spot Staphytect Plus, Catalog #DR0100M, 120 tests/kit. Oxoid Ltd., Wade road, Basingstoke, Hants, UK. Latex slide agglutination test for the differentiation of staphylococcus aureus by detection of clumping factor, Protein A and certain polysaccarides found in methicillin-resistant S. aureus (MRSA) from those staphylococci that do not possess these properties.

    Recall: Z-0817-2010 · Initiated July 20, 2009

    Recall

    Recall Number
    Z-0817-2010
    Event Number
    53553
    Firm
    Remel, Inc
    FEI Number
    1924669
    Product Code
    JWX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 20, 2009
    Posted
    February 23, 2010
    Terminated
    April 25, 2012
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519

    Description

    Oxoid dry Spot Staphytect Plus, Catalog #DR0100M, 120 tests/kit. Oxoid Ltd., Wade road, Basingstoke, Hants, UK. Latex slide agglutination test for the differentiation of staphylococcus aureus by detection of clumping factor, Protein A and certain polysaccarides found in methicillin-resistant S. aureus (MRSA) from those staphylococci that do not possess these properties.

    Reason

    The products may give false positive results with some non-Staphylococcus aureus strains

    Action

    Thermo Fischer Scientific, Remel Inc. issued letters dated July 20, 2009 via regular mail explaining the reason for recall, risks involved, and requested they discard all remaining product. A Product Inventory Checklist was enclosed to report the amount of product their customer discarded. A second letter dated October 19, 2009 was issued via certified mail. For further information, contact Thermo Fischer Scientific, Remel Inc. at 1-800-255-6730, Extension 3304185.

    Distribution

    Nationwide Distribution -- MN, CT, FL, GA, CA, NY, MI, MO, PA, and IL.

    Quantity

    27 kits