Events

Recall of AdvanDx EK/P. aeruginosa PNA FISH

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
    56997
  • Event Risk Class
    Class 2
  • Event Number
    Z-0491-2011
  • Event Initiated Date
    2010-10-08
  • Event Date Posted
    2010-12-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95145
  • 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, enterobacteriaceac - Product Code JSS
  • 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.

Device

AdvanDx EK/P. aeruginosa PNA FISH
  • Model / Serial
    All codes
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including IL, MI, NY, and PA and the country of Denmark
  • Product 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.
  • 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