Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall TDx/TDxFLx

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall TDx/TDxFLx see related information
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  
Product Classification unknown device name - Product Code 91
Product TDx/TDxFLx








TDx/TDxFLX Tricyclic Antidepressant Reagent
Distributed under the following label:
TDx/TDxFLX, Abbott Laboratories USA, North Chicago, IL 60064
Code Information List no. 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		 Unexpected false positive TCA results
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
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 = 91 and Original Applicant = ABBOTT LABORATORIES
-
-