Z-0280-2012

Inova Diagnostic Inc., NOVA Lite ANA KSL Kit Part Number: 708390. in vitro diagnostic

Name: Z-0280-2012 Inova Diagnostic Inc., NOVA Lite ANA KSL Kit Part Number: 708390. in vitro diagnostic
Creator: Inova Diagnostics Incorporated
Published: 2011-09-26
License: https://open.fda.gov/license/

Inova Diagnostics, Inc. / initiated 2011-09-26 / Terminated / root cause: labeling and UDI

FDA source

Inova Diagnostics Incorporated began a recall of Inova Diagnostic Inc., NOVA Lite ANA KSL Kit Part Number: 708390. in vitro diagnostic on 2011-09-26. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0280-2012
Status: Terminated
Initiated: 2011-09-26
Posted: 2011-11-23
Terminated: 2012-04-04
Recalling firm: Inova Diagnostics, Inc.
Product: Inova Diagnostic Inc., NOVA Lite ANA KSL Kit Part Number: 708390. in vitro diagnostic.
Product code: DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
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.
Root cause tag: labeling and UDI
FDA 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 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.
Product codes and lots: 070409, 070491, 170069, 17014E1, 170214E2, 170440

Product code DHN

K901596Class IINova Lite(tm) Ana KslInova Diagnostics, Inc. / cleared 1990-05-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)