Device recall

Z-1942-2010: Inova Diagnostics BINDAZYME Human C1q binding Circulating Immune Complex EIA…

FDA device recall · Class III · Inova Diagnostics Incorporated

Key facts

Recall number (Z-number) Z-1942-2010
Recall event 55801
Product Inova Diagnostics BINDAZYME Human C1q binding Circulating Immune Complex EIA Kit, Part#: MK021
Product code DAK
Recalling firm Inova Diagnostics Incorporated
Recall class Class III
Status Terminated
Termination date Jun 30, 2010
510(k) numbers K031563
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

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