Device recall

Z-1035-2007: AxSYM CMV IgM Reagent Pack; list 05C78; 100 test pack; in-vitro diagnostic…

FDA device recall · Class II · Abbott Laboratories

Key facts

Recall number (Z-number) Z-1035-2007
Recall event 37887
Product AxSYM CMV IgM Reagent Pack; list 05C78; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064
Product code LKQ
Recalling firm Abbott Laboratories
Recall class Class II
Status Terminated
Termination date May 18, 2008
FEI number 1415939

At a glance

  • None Linked 510(k)s
  • 10–99 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)