Events

Recall of Device Recall AdvanDx GramNegative QuickFISH BC

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by AdvanDx, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    67069
  • Event Risk Class
    Class 3
  • Event Number
    Z-0619-2014
  • Event Initiated Date
    2013-12-11
  • Event Date Posted
    2014-01-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124653
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Kit, identification, enterobacteriaceae - Product Code JSS
  • 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 techwupport@advandx.com. For questions regarding this recall call 781-376-0009.

Device

Device Recall AdvanDx GramNegative QuickFISH BC
  • Model / Serial
    Lot codes US: 04813C, 7413, 08113 exp. 2013-12  Lot codes OUS: 03113A 04213A 04813B
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including CA, IL, IN, OH, NJ, MI , MO, NY, WI. Internationally to Denmark.
  • Product 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
  • Manufacturer
    AdvanDx, Inc.

Manufacturer

AdvanDx, Inc.
  • Manufacturer Address
    AdvanDx, Inc., 10a Roessler Rd, Woburn MA 01801-6208
  • Manufacturer Parent Company (2017)
    Advandx, Inc.
  • Source
    USFDA