BEUDAMED
    FDA Enforcement Class III 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 · Reported January 8, 2014

    Enforcement

    Recall Number
    Z-0619-2014
    Event ID
    67069
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    AdvanDx, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 8, 2014
    Initiation Date
    December 11, 2013
    Classification Date
    January 2, 2014
    Termination Date
    January 13, 2014
    Address
    10a Roessler Rd, Woburn, MA, 01801-6208, United States

    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

    Code Info

    Lot codes US: 04813C, 7413, 08113 exp. 2013-12 Lot codes OUS: 03113A 04213A 04813B

    Distribution

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

    Quantity

    49 kits US; 17 kits OUS