BEUDAMED
    FDA Recall Terminated

    Lifesign Staph Latex Kits, 6 ml For In Vitro Diagnostic Use Catalog Number: 50051 Manufactured for Lifesign LLC , Somerset, NJ 08873 A rapid latex agglutination test to detect Protein A and/or clumping factor for Staph aureus from culture media.

    Recall: Z-1110-2010 · Initiated January 15, 2010

    Recall

    Recall Number
    Z-1110-2010
    Event Number
    54267
    Firm
    NERL Diagnostics Corporation
    FEI Number
    1215667
    Product Code
    JWX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 15, 2010
    Posted
    March 12, 2010
    Terminated
    October 5, 2011
    Address
    12 Almeida St, East Providence, RI, 02914-1002

    Description

    Lifesign Staph Latex Kits, 6 ml For In Vitro Diagnostic Use Catalog Number: 50051 Manufactured for Lifesign LLC , Somerset, NJ 08873 A rapid latex agglutination test to detect Protein A and/or clumping factor for Staph aureus from culture media.

    Reason

    Unreactive Staph latex reagent

    Action

    NERL Diagnostics notified distributors on January 15, 2010, by letter to advise of the recall and request they examine inventory, discontinue use of affected lot numbers and discard any remaining inventory. In addition, if product was further distributed, notify the customers of the product recall. If you have any questions, please telephone 1-401-824-2046.

    Distribution

    NJ

    Quantity

    125 kits