Recall Z-0325-04 ยท LFG Radioimmunoassay, Tricyclic Antidepressant Drugs
Abbott Health Products, Inc.
TDx/TDxFLx Tricyclic Antidepressants Reagent. Distributed under the following label: TDx/TDxFLx Antidepressants Reagents, Abbott Laboratories USA, North Chicago, IL 60064.
| Date | Jan 10, 2004 (initiated Nov 17, 2003) |
| Status | Terminated |
| Reason | Drug product cross reacts with the Tricyclic Antidepressants (TCA) assay. |
| Root cause | Other |
| Action | 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. |
| Distribution | Distribution was nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K853113 | TD TRICYCLIC ANTIDEPRESSANTS Abbott Laboratories, Aug 12, 1985 |