BEUDAMED
    FDA Recall Terminated

    SLIDEX Staph kit (250 Tests). The SLIDEX Staph-Kit is a rapid latex and red blood cell agglutination test for the identification of Staphylococcus aureus strains from culture media.

    Recall: Z-1045-2012 · Initiated December 21, 2011

    Recall

    Recall Number
    Z-1045-2012
    Event Number
    60990
    Firm
    bioMerieux, Inc.
    FEI Number
    3002769706
    Product Code
    JWX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 21, 2011
    Posted
    February 16, 2012
    Terminated
    September 17, 2013
    Address
    100 Rodolphe St, Durham, NC, 27712-9402

    Description

    SLIDEX Staph kit (250 Tests). The SLIDEX Staph-Kit is a rapid latex and red blood cell agglutination test for the identification of Staphylococcus aureus strains from culture media.

    Reason

    Reports of false negative results in organism identification.

    Action

    Biomerieux sent an "URGENT PRODUCT REMOVAL NOTICE" dated December 21, 2011 to the affected customer. The letter describes the product, problem, and actions to be taken by the customer. The letter instructs the customer to stop using and to destroy the affected products. The firm recommends steps to follow when interpreting results. An acknowledgement and Product Replacement Form was enclosed for the customer to complete and return to the firm. Contact Biomerieux Customer Service representative at (800) 682-2666 for information regarding this notice.

    Distribution

    Distributed to one customer in California.

    Quantity

    100 kits