BEUDAMED
    FDA Recall Terminated

    AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog Number: QFGNRBC1-25 Gram-Negative QuickFISH BC provides rapid identification of Escherichia coli, and/or Pseudomonas aeruginosa, and/or Klebsiella pneumoniae directly from GNR-positive blood cultures

    Recall: Z-0619-2014 · Initiated December 11, 2013

    Recall

    Recall Number
    Z-0619-2014
    Event Number
    67069
    Firm
    AdvanDx, Inc.
    FEI Number
    3004080598
    Product Code
    JSS
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    December 11, 2013
    Posted
    January 2, 2014
    Terminated
    January 13, 2014
    Address
    10a Roessler Rd, Woburn, MA, 01801-6208

    Description

    AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog Number: QFGNRBC1-25 Gram-Negative QuickFISH BC provides rapid identification of Escherichia coli, and/or Pseudomonas aeruginosa, and/or Klebsiella pneumoniae directly from GNR-positive blood cultures

    Reason

    Kits incompatible with certain fluorescence microscope light sources

    Action

    AdvanDx issued an email notification along with a PDF file of the new package insert to each customer followed by written notification dated December 6, 2013 and a paper copy of the new package insert via Fed Ex courier. All customers received an acknowledgement form to fill out and return to AdvanDx so that the effectiveness of the replacement can be evaluated. All existing inventory of Gram-Negative QuickFISH BC will be repackaged with the new package inert Customers with questions were instructed to contact AdvanDx Technical Support at 1-866-376-0009 or [email protected]. For questions regarding this recall call 781-376-0009.

    Distribution

    Worldwide Distribution - USA including CA, IL, IN, OH, NJ, MI , MO, NY, WI. Internationally to Denmark.

    Quantity

    49 kits US; 17 kits OUS