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U.S. Department of Health and Human Services

Class 2 Device Recall AxSYM

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  Class 2 Device Recall AxSYM 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-0689-03
Recall Event ID 25220
510(K)Number K953761  
Product Classification unknown device name - Product Code 91
Product AxSYM Tricyclic Antidpressants Reagent. Distributied under the following label:
Abbott Laboratories USA, North Chicago, IL 60064
Code Information List no. 3B34-20
Recalling Firm/
Abbott Health Products, Inc.
Hwy 2 Km 58.0
Barceloneta PR 00617
For Additional Information Contact Nydia I. Cancel
Manufacturer Reason
for Recall
Unexpected false positive TCA results
FDA Determined
Cause 2
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