Class 2 Device Recall TDx/TDxFLX

• Date Initiated by Firm: November 17, 2003
• Date Posted: January 10, 2004
• Recall Status: Terminated on November 02, 2004
• Recall Number: Z-0325-04
• Recall Event ID: 27843
• 510(K)Number: K853113
• Product Classification: Radioimmunoassay, Tricyclic Antidepressant Drugs - Product Code LFG
• Product: TDx/TDxFLx Tricyclic Antidepressants Reagent. Distributed under the following label: TDx/TDxFLx Antidepressants Reagents, Abbott Laboratories USA, North Chicago, IL 60064.
• Code Information: Product List number: 9681-60
• Recalling Firm/ Manufacturer: Abbott Health Products, Inc.; Hwy 2 Km 58.0; Barceloneta PR 00617
• For Additional Information Contact: Nydia I. Cancel; 787-846-8256
• Manufacturer Reason for Recall: Drug product cross reacts with the Tricyclic Antidepressants (TCA) assay.
• FDA Determined Cause: Other
• 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.
• Distribution: Distribution was nationwide.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LFG and Original Applicant = ABBOTT LABORATORIES