Z-0691-03

TDx/TDxFLx TDx/TDxFLX Tricyclic Antidepressant Reagent Distributed under the following label: TDx/TDxFLX...

Name: Z-0691-03 TDx/TDxFLx TDx/TDxFLX Tricyclic Antidepressant Reagent Distributed under the following label: TDx/TDxFLX...
Creator: Abbott Health Products, Inc.
Published: 2002-12-11
License: https://open.fda.gov/license/

Abbott Diagnostic International, Ltd. / initiated 2002-12-11 / Terminated

FDA source

Abbott Health Products, Inc. began a recall of TDx/TDxFLx TDx/TDxFLX Tricyclic Antidepressant Reagent Distributed under the following label: TDx/TDxFLX, Abbott Laboratories USA, North Chicago, IL 60064 on 2002-12-11. The reason FDA records is "Unexpected false positive TCA results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0691-03
Status: Terminated
Initiated: 2002-12-11
Posted: 2003-03-29
Terminated: 2004-06-02
Recalling firm: Abbott Diagnostic International, Ltd.
Product: TDx/TDxFLx TDx/TDxFLX Tricyclic Antidepressant Reagent Distributed under the following label: TDx/TDxFLX, Abbott Laboratories USA, North Chicago, IL 60064
Product code: 91
Reason for recall: Unexpected false positive TCA results
FDA root cause: Other
Action: A Device Correction letter was mail to all customers on 12 /11/02. The letter explained the reason for the recall and provided specific instructions.
Distribution: Distribution was nationwide, VA/DOD accounts. The foreign distribution was as follows: Mexico, Venezuela, Colombia, Chile, Uruguay, Argentina, Brazil, Canada, England, Japan, Singapore, Hong Kong, Taiwan, Thailand, Costa Rica, New Zealand and Panama
Product codes and lots: List no. 9681-60

Product code 91

K853113Class IITd Tricyclic AntidepressantsAbbott Laboratories / cleared 1985-08-12

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)