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Terminated

ADx Tricyclic Antidepressants Reagent. Distributed under the following label: ADx, Abbott Laboratories USA, North Chicago, IL 60064

FDA Recall Z-0690-03 · 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.

K833113REPORTING INTEGRATOR 3392AHewlett-Packard Co. · 1983-11-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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