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Terminated

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

FDA Recall Z-0323-04 · Posted 2004-01-10

Recalling FirmAbbott Health Products, Inc.
Recall StatusTerminated
Product CodeLDM
Date Initiated2003-11-17
Date Terminated2004-11-02

Reason for Recall

Drug product cross reacts with the Tricyclic Antidepressants (TCA) assay.

Firm 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.

Root Cause

Other

Distribution Pattern

Distribution was nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K953761AXSYM TRICYCLIC ANTIDEPRESSANTSAbbott Laboratories · 1995-11-22

Official Source

View FDA Recall →

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

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