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Class 2 Device Recall TDx/TDxFLx |
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Date Initiated by Firm |
December 11, 2002 |
Date Posted |
March 29, 2003 |
Recall Status1 |
Terminated 3 on June 02, 2004 |
Recall Number |
Z-0691-03 |
Recall Event ID |
25220 |
510(K)Number |
K853113
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Product Classification |
unknown device name - Product Code 91
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Product |
TDx/TDxFLx
TDx/TDxFLX Tricyclic Antidepressant Reagent Distributed under the following label: TDx/TDxFLX, Abbott Laboratories USA, North Chicago, IL 60064
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Code Information |
List no. 9681-60 |
Recalling Firm/ Manufacturer |
Abbott Health Products, Inc. Hwy 2 Km 58.0 Barceloneta PR 00617
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For Additional Information Contact |
Nydia I. Cancel 787-846-8256
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Manufacturer Reason for Recall |
Unexpected false positive TCA results
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FDA Determined Cause 2 |
Other |
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. |
Distribution |
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 |
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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.
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510(K) Database |
510(K)s with Product Code = 91 and Original Applicant = ABBOTT LABORATORIES
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