Z-0323-04

AxSYM Tricyclic Antidepressants Reagent, Distributed under the following label: AxSYM Tricyclic...

Name: Z-0323-04 AxSYM Tricyclic Antidepressants Reagent, Distributed under the following label: AxSYM Tricyclic...
Creator: Abbott Health Products, Inc.
Published: 2003-11-17
License: https://open.fda.gov/license/

Abbott Diagnostic International, Ltd. / initiated 2003-11-17 / Terminated

FDA source

Abbott Health Products, Inc. began a recall of AxSYM Tricyclic Antidepressants Reagent, Distributed under the following label: AxSYM Tricyclic Antidepressants Reagents, Abbott Laboratories USA, North... on 2003-11-17. The reason FDA records is "Drug product cross reacts with the Tricyclic Antidepressants (TCA) assay". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0323-04
Status: Terminated
Initiated: 2003-11-17
Posted: 2004-01-10
Terminated: 2004-11-02
Recalling firm: Abbott Diagnostic International, Ltd.
Product: AxSYM Tricyclic Antidepressants Reagent, Distributed under the following label: AxSYM Tricyclic Antidepressants Reagents, Abbott Laboratories USA, North Chicago, IL 60064
Product code: LDM Instrumentation, High Pressure Liquid Chromatography
Reason for recall: Drug product cross reacts with the Tricyclic Antidepressants (TCA) assay.
FDA 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.
Product codes and lots: Product list number: 3B34-20

Product code LDM

K953761Class IIAxsym Tricyclic AntidepressantsAbbott Laboratories / cleared 1995-11-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)