Events

Recall of NOVA Lite ANA KSL Kit

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

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
    60219
  • Event Risk Class
    Class 3
  • Event Number
    Z-0280-2012
  • Event Date Posted
    2011-11-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104801
  • 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
    in vitro diagnostic - Product Code DHN
  • Reason
    The nova lite ana ksl kit label has the wrong fill volume for the ifa system negative control (p/n 508186) with 1ml. the component in the kit is correctly labeled and filled with the 0.5ml fill volume.
  • Action
    On 9/26/11, Inova Diagnostics forwarded an Urgent Advisory Notice and Product Advisory Notice Fax Back Form to all their customers who purchased the Nova Lite Ana KSL, Product Code: 708390. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to complete the attached fax back form indicating how many of these kits they have in their inventory, quantity destroyed, method of destruction and the quantity of kits that need to be replaced. Customers were also instructed to notify their customers of the advisory notice. Customers were instructed to contact Tana Keivens with any questions or comments at (858) 586-9900 ext 351.

Device

NOVA Lite ANA KSL Kit
  • Model / Serial
    070409, 070491, 170069, 17014E1, 170214E2, 170440
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution to: USA, Mexico, Kuwait, Uraguay, Romania, Italy, Philippines, India, Malaysia, Algeria, Czechoslovakia, Brazil, Colombia, Ireland, Korea, and Saudi Arabia.
  • Product Description
    Inova Diagnostic Inc., NOVA Lite ANA KSL Kit || Part Number: 708390. in vitro diagnostic.
  • Manufacturer
    Inova Diagnostics Incorporated

Manufacturer

Inova Diagnostics Incorporated
  • Manufacturer Address
    Inova Diagnostics Incorporated, 9900 Old Grove Rd, San Diego CA 92131-1638
  • Manufacturer Parent Company (2017)
    Werfenlife Sa.
  • Source
    USFDA