TDx/TDxFLx Tricyclic Antidepressants Reagent. Distributed under the following label: TDx/TDxFLx Antidepressants Reagents, Abbott Laboratories USA, North Chicago, IL 60064.
FDA Recall Z-0325-04 · Posted 2004-01-10
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Recalling FirmAbbott Health Products, Inc.
Recall StatusTerminated
Product CodeLFG
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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