TDx/TDxFLx TDx/TDxFLX Tricyclic Antidepressant Reagent Distributed under the following label: TDx/TDxFLX, Abbott Laboratories USA, North Chicago, IL 60064
FDA Recall Z-0691-03 · Posted 2003-03-29
Recalling FirmAbbott Health Products, Inc.
Recall StatusTerminated
Product Code91
Date Initiated2002-12-11
Date Terminated2004-06-02
Reason for Recall
Unexpected false positive TCA results
Firm 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.
Root Cause
Other
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.