BEUDAMED
    FDA Recall Terminated

    AdvanDx EK/P. aeruginosa PNA FISH- Culture Identification Kit for identification of E. coli and/or K. pneumoniae and P. aeruginosa bacteremia (In-Vitro Diagnostic) Catalog number: KT008 EK/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and/or Klebsiella pneumoniae and Pseudomonas aeruginosa on smears made from positive blood cultures containing Gram-negative rods.

    Recall: Z-0491-2011 · Initiated October 8, 2010

    Recall

    Recall Number
    Z-0491-2011
    Event Number
    56997
    Firm
    AdvanDx, Inc.
    FEI Number
    3004080598
    Product Code
    JSS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 8, 2010
    Posted
    December 1, 2010
    Terminated
    June 6, 2011
    Address
    10a Roessler Rd, Woburn, MA, 01801-6208

    Description

    AdvanDx EK/P. aeruginosa PNA FISH- Culture Identification Kit for identification of E. coli and/or K. pneumoniae and P. aeruginosa bacteremia (In-Vitro Diagnostic) Catalog number: KT008 EK/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and/or Klebsiella pneumoniae and Pseudomonas aeruginosa on smears made from positive blood cultures containing Gram-negative rods.

    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 sent an e-mail notification along with a PDF file to all customers on October 8, 2010, followed by written notification dated October 6, 2010. The letter identified the product, the problem, and the action the customers should take. Customers were instructed to replace the package insert(s) included with any kits in their inventory with the enclosed package insert(s). Customers were also instructed to fill out the enclosed Acknowledgement of Receipt Form and return it to AdvanDx to confirm that they received the new package insert. For questions regarding this recall contact AdvanDx Technical Support at 1-888-376-0009.

    Distribution

    Worldwide Distribution - USA including IL, MI, NY, and PA and the country of Denmark

    Quantity

    27 kits