FDA Medical Device Recalls (openFDA)
Inova Diagnostics Incorporated: Inova Diagnostic Inc., NOVA Lite ANA KSL Kit Part Number: 708390. in vitro diagnostic.
- Recall number
- Z-0280-2012
- Recalling firm
- Inova Diagnostics Incorporated
- Product
- Inova Diagnostic Inc., NOVA Lite ANA KSL Kit Part Number: 708390. in vitro diagnostic.
- Status
- Terminated
- Initiated
- 2011-09-26
- Posted
- 2011-11-23
- Terminated
- 2012-04-04
- 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.
- Root cause
- 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
- 500 kits
- Distribution
- Worldwide distribution to: USA, Mexico, Kuwait, Uraguay, Romania, Italy, Philippines, India, Malaysia, Algeria, Czechoslovakia, Brazil, Colombia, Ireland, Korea, and Saudi Arabia.
- Lot, serial or model codes
- 070409, 070491, 170069, 17014E1, 170214E2, 170440
- 510(k) numbers
- ["K901596"]
- PMA numbers
- not on file
- Product code
- DHN
- Firm FEI
- 2026994
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28