Device recall

Z-0323-04: AxSYM Tricyclic Antidepressants Reagent, Distributed under the following label…

FDA device recall · Class II · Abbott Health Products, Inc.

Key facts

Recall number (Z-number) Z-0323-04
Recall event 27843
Product AxSYM Tricyclic Antidepressants Reagent, Distributed under the following label: AxSYM Tricyclic Antidepressants Reagents, Abbott Laboratories USA, North Chicago, IL 60064
Product code LDM
Recalling firm Abbott Health Products, Inc.
Recall class Class II
Status Terminated
Termination date Nov 2, 2004
510(k) numbers K953761
FEI number 2623532

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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