Events

Recall of E. coli/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
    63199
  • Event Risk Class
    Class 2
  • Event Number
    Z-0116-2013
  • Event Initiated Date
    2012-09-14
  • Event Date Posted
    2012-10-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112961
  • 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
    Some strains of pseudomonas putida cross-react with the p. aeruginosa pna probe used in e. coli/p. aeruginosa pna fish (kt007) due to a sequence similarity resulting in a cross-reaction that may produce a red-positive signal.
  • Action
    AdvanDx notified customers on September 14, 2012 by email along with a PDF file of the new package insert to each contact followed by written notification and a paper copy of the new package insert via FedEx courier. The notification described the product, problem and actions to be taken. The customers were instructed to destroy the package insert in any existing inventory of the kit and replace it with the enclosed package insert. "Note: All shipments of E. coli/P.aeruginosa PNA FISH as of September 14, 2012, will contain this new package insert." The customers were also instructed to complete and return the Acknowledgement of Receipt form to AdvanDX: Regulatory Affairs; 400 TradeCenter, Suite 6990, Woburn, MA 01801-7476; Fax to: +1 (781) 376-0111; bsc@advandx.com. If you have any questions or requests for further information, please contact AdvanDx Technical Support: US (Toll-Free): 1-866-376-0009, techsupport@advandx.com.

Device

E. coli/P. aeruginosa PNA FISH
  • Model / Serial
    Lot Numbers: 01812A-US, 03412A-US and 00512A-EU  Exp Date: 12-2013
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including: CA, FL, IL, MI, and NJ; and country of: Great Britain.
  • Product Description
    AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Escherichia coli and Pseudomonas aeruginosa || Catalog Number : KT007 || Usage: E. coli/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and Pseudomonas aeruginosa on smears of positive blood cultures containing Gram-negative rods. The E.coli/P. aeruginosa PNA FISH assay is indicated for use as an aid in the diagnosis of E. coli and/or P. aeruginosa bacteremia.
  • Manufacturer
    Advandx Inc

Manufacturer

Advandx Inc
  • Manufacturer Address
    Advandx Inc, 400 Tradecenter, Ste 6990, Woburn MA 01801
  • Manufacturer Parent Company (2017)
    Advandx, Inc.
  • Source
    USFDA