BEUDAMED
    FDA Recall Terminated

    AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa Catalog number: KT011. GNR Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods observed on Gram stain. Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth. The GNR Traffic Light PNA FISH assay is indicated for use as an aid in the diagnosis of coli, and/or K. pneumoniae, and/or P. aeruginosa bacteremia.

    Recall: Z-0112-2013 · Initiated September 14, 2012

    Recall

    Recall Number
    Z-0112-2013
    Event Number
    63215
    Firm
    Advandx Inc
    FEI Number
    3004080598
    Product Code
    JSS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 14, 2012
    Posted
    October 22, 2012
    Terminated
    March 5, 2013
    Address
    400 Tradecenter, Ste 6990, Woburn, MA, 01801

    Description

    AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa Catalog number: KT011. GNR Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods observed on Gram stain. Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth. The GNR Traffic Light PNA FISH assay is indicated for use as an aid in the diagnosis of coli, and/or K. pneumoniae, and/or P. aeruginosa bacteremia.

    Reason

    GNR Traffic Light PNA Fish may have false positive results with Pseudomonas putida and Pseudomonas fulva

    Action

    AdvanDx sent a "GNR Traffic Light PNA FISH (KT011) Package Insert Replacement" letter dated September 14, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. All customers received an Acknowledgement Form to complete and return to AdvanDx so that the effectiveness of the replacement can be evaluated. Contact AdvanDx Technical Support at 1-866-376-0009 for questions regarding this notice.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Austria, Denmark, Italy, Germany, Finland, and UK.

    Quantity

    187 kits