Device recall

Z-0280-2012: Inova Diagnostic Inc., NOVA Lite ANA KSL Kit Part Number: 708390. in vitro…

FDA device recall · Class III · Inova Diagnostics Incorporated

Key facts

Recall number (Z-number) Z-0280-2012
Recall event 60219
Product Inova Diagnostic Inc., NOVA Lite ANA KSL Kit Part Number: 708390. in vitro diagnostic.
Product code DHN
Recalling firm Inova Diagnostics Incorporated
Recall class Class III
Status Terminated
Termination date Apr 4, 2012
510(k) numbers K901596
FEI number 2026994

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)