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U.S. Department of Health and Human Services

Class 3 Device Recall NOVA Lite ANA KSL Kit

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  Class 3 Device Recall NOVA Lite ANA KSL Kit see related information
Date Initiated by Firm September 26, 2011
Date Posted November 23, 2011
Recall Status1 Terminated 3 on April 04, 2012
Recall Number Z-0280-2012
Recall Event ID 60219
510(K)Number K901596  
Product Classification in vitro diagnostic - Product Code DHN
Product Inova Diagnostic Inc., NOVA Lite ANA KSL Kit
Part Number: 708390. in vitro diagnostic.
Code Information 070409, 070491, 170069, 17014E1, 170214E2, 170440
Recalling Firm/
Manufacturer		 Inova Diagnostics Incorporated
9900 Old Grove Rd
San Diego CA 92131-1638
For Additional Information Contact
858-586-9900
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Process change control
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.
Quantity in Commerce 500 kits
Distribution Worldwide distribution to: USA, Mexico, Kuwait, Uraguay, Romania, Italy, Philippines, India, Malaysia, Algeria, Czechoslovakia, Brazil, Colombia, Ireland, Korea, and Saudi Arabia.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DHN and Original Applicant = INOVA DIAGNOSTICS, INC.
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