Device recall

Z-1462-2008: AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0; List Number: 3D54-08…

FDA device recall · Class III · Abbott Laboratories

Key facts

Recall number (Z-number) Z-1462-2008
Recall event 46740
Product AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0; List Number: 3D54-08; Abbott La boratories, Diagnostics Division, Abbott Park, IL 60064
Product code DKZ
Recalling firm Abbott Laboratories
Recall class Class III
Status Terminated
Termination date Dec 1, 2009
510(k) numbers K953115
FEI number 1415939

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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)