Events

Recall of Device Recall E.faecalis/OE 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
    56064
  • Event Risk Class
    Class 2
  • Event Number
    Z-2315-2010
  • Event Initiated Date
    2010-06-08
  • Event Date Posted
    2010-08-31
  • 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=92578
  • 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
    fish (fluorescent in situ hybridization) kit, protein nucleic acid, enterococcus faecalis - Product Code OAH
  • Reason
    Some strains of streptococus anginosus cross-reach with e. faecalis/oe pna fish to produce a false positive green signal.
  • Action
    The firm, AdvanDx, sent a letter dated June 8, 2010, and email notification on June 11, 2010, to all customers. The letter described the product, problem and action to be taken by customers. AdvanDx notified the customers that there was a change to the package insert under "limitations" to include the statement "some strains of Streptococcus anginosus produce a false green positive fluorescence due to sequence similarities and enclosed a package insert for all E. facealis/OE PNA FISH (KT003) kits. The customers were instructed to replace the Package Insert (revision B) included with any kits in their inventory with the enclosed Package Insert (revision C). Note: All shipments of E. faecalis/OE PNA FISH, as of June 14, 2010, will contain this new package insert. If you have any questions or requests for further information, please contact AdvanDx Technical Support at US (Toll Free): 1-800-376-0009 or email techsupport@advandx.com.

Device

Device Recall E.faecalis/OE PNA Fish
  • Model / Serial
    Catalog number KT003
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA and countries including Danmark, Finland and Sverige (European).
  • Product Description
    E.faecalis/OE PNA FISH || Intended Use: E. faecalis/OE PNA FISH" (Cat. No. KT003) is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Enterococcus faecalis and selected other enterococci (OE) from blood cultures. E. faecalis/OE PNA FISH provides rapid identification of E. faecalis and selected other enterococci (OE) on smears made from positive blood cultures and is compatible with all major blood culture media
  • 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