BEUDAMED
    FDA Recall Terminated

    AdvanDx E. coli/P. aeruginosa PNA FISH Culture Identification Kit for the diagnosis of E. coli and/or P. aeruginosa bacteremia Catalog Number: KT007

    Recall: Z-0490-2011 · Initiated October 6, 2010

    Recall

    Recall Number
    Z-0490-2011
    Event Number
    57002
    Firm
    AdvanDx, Inc.
    FEI Number
    3004080598
    Product Code
    JSS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 6, 2010
    Posted
    November 29, 2010
    Terminated
    June 6, 2011
    Address
    10a Roessler Rd, Woburn, MA, 01801-6208

    Description

    AdvanDx E. coli/P. aeruginosa PNA FISH Culture Identification Kit for the diagnosis of E. coli and/or P. aeruginosa bacteremia Catalog Number: KT007

    Reason

    Strains of Acinetobacter radioresistens cross-react with both E. coli/P. aeruginosa PNA FISH and EK/P. aeruginosa PNA FISH to produce a false positive red signal.

    Action

    AdvanDx issued a customer letter dated October 6, 2010 with a PDF file of a new package insert and an acknowledgement form to fill out and return to AdvanDx. Customers were instructed to replace the package insert in any existing inventory with the enclosed package insert. Customers can contact AdvanDx technical support about this action at 1-866-376-0009.

    Distribution

    Worldwide Distribuition: Throughtout the US, and to the countries of Denmark, Italy, Sweden, and UK.

    Quantity

    260 units