Device recall

Z-0779-2007: American Diagnostica Inc. ACTICLOT dPT Reference 824 in vitro diagnostic

FDA device recall · Class II · American Diagnostica, Inc.

Key facts

Recall number (Z-number) Z-0779-2007
Recall event 37762
Product American Diagnostica Inc. ACTICLOT dPT Reference 824 in vitro diagnostic
Product code GIR
Recalling firm American Diagnostica, Inc.
Recall class Class II
Status Terminated
Termination date Jul 6, 2016
510(k) numbers K052124
FEI number 1220602

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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