Events

Recall of AdvanDx E. coli/P. aeruginosa PNA FISH Culture Identification Kit

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
    57002
  • Event Risk Class
    Class 2
  • Event Number
    Z-0490-2011
  • Event Initiated Date
    2010-10-06
  • Event Date Posted
    2010-11-29
  • 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=95159
  • 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
    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 issued a customer letter dated October 6, 2010 with a PDF file of a new package insert and an acknowledgement form to fill out and return to AdvanDx. Customers were instructed to replace the package insert in any existing inventory with the enclosed package insert. Customers can contact AdvanDx technical support about this action at 1-866-376-0009.

Device

AdvanDx E. coli/P. aeruginosa PNA FISH Culture Identification Kit
  • Model / Serial
    Lot Codes Exp date 04310A-U8 2012-08; 03610A-U8 2012-08 ; 02110A-EU 2011-05 ; 02010A-US 2011-05 ; 00410A-US 2011-05 ; 00110A-US 2010-11 ; 07509A-EU 2010-11 ; 07009A-US 2010-11 ; 06409A-US 2010-11 ; 02909A-EU 2010-02 ; 02309A-US 2010-02;
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribuition: Throughtout the US, and to the countries of Denmark, Italy, Sweden, and UK.
  • Product Description
    AdvanDx E. coli/P. aeruginosa PNA FISH Culture Identification Kit for the diagnosis of E. coli and/or P. aeruginosa bacteremia || Catalog Number: KT007
  • 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