Abbott Laboratories HPD/ADD/GPRD 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Lot Codes / Batch Numbers
lot numbers 07747M100 and 07747M101
Products Sold
lot numbers 07747M100 and 07747M101
Abbott Laboratories HPD/ADD/GPRD is recalling ARCHITECT CA 19-9 Reagent Kit, list 6C04-20 (1 x 100 tests) and 6C04-25 (4 x 100 tests), Abbott labo due to The reagent lots may produce patient results that are lower than expected when compared to other lots of in-date reagents.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The reagent lots may produce patient results that are lower than expected when compared to other lots of in-date reagents.
Recommended Action
Per FDA guidance
Abbott international affiliates were notified of the recall by e-mail on 3/23/04, and requested to notify their customers.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026