Abbott Health Products, Inc. ADx Tricyclic Antidepressants Reagent. Distributed under the following label: ADx Tricyclic Antidepressants Reagents, Abbott Laboratories USA, North Chicago, IL 60064 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ADx Tricyclic Antidepressants Reagent. Distributed under the following label: ADx Tricyclic Antidepressants Reagents, Abbott Laboratories USA, North Chicago, IL 60064
Brand
Abbott Health Products, Inc.
Lot Codes / Batch Numbers
Product List number: 9681-55.
Products Sold
Product List number: 9681-55.
Abbott Health Products, Inc. is recalling ADx Tricyclic Antidepressants Reagent. Distributed under the following label: ADx Tricyclic Antidepr due to Drug product cross reacts with the Tricyclic Antidepressants (TCA) assay.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Drug product cross reacts with the Tricyclic Antidepressants (TCA) assay.
Recommended Action
Per FDA guidance
The Important Information Letter dated 11/17/03 was mailed to all ADx, TDx/TDxFL and AxSYM TCA reagent customers. The letters were sent to customers by Federal express Priority mail. The letter recommended contacting all customers who have received the reagents within the last 15 months.
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