FDA Device

ARCHITECT CA 19-9 Reagent Kit, list 6C04-20 (1 x 100 tests) and 6C04-25 (4 x 100 tests), Abbott laboratories, Abbott Park, IL 60064 U.S.A.

Hazard

The reagent lots may produce patient results that are lower than expected when compared to other lots of in-date reagents.

What You Should Do

Remedy

Abbott international affiliates were notified of the recall by e-mail on 3/23/04, and requested to notify their customers.

Products

ARCHITECT CA 19-9 Reagent Kit, list 6C04-20 (1 x 100 tests) and 6C04-25 (4 x 100 tests), Abbott laboratories, Abbott Park, IL 60064 U.S.A.
Brand
Abbott Laboratories HPD/ADD/GPRD
UPC
lot numbers 07747M100 and 07747M101

Units Affected

1,987 kits