Recall Z-0280-2012 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Inova Diagnostics Incorporated
Inova Diagnostic Inc., NOVA Lite ANA KSL Kit Part Number: 708390. in vitro diagnostic.
| Date | Nov 23, 2011 (initiated Sep 26, 2011) |
| Status | Terminated |
| 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 notic |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K901596 | NOVA LITE(TM) ANA KSL Inova Diagnostics, Inc., May 2, 1990 |