| | Class 2 Device Recall TDx/TDxFLx |  |
| Date Initiated by Firm | December 11, 2002 |
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| Date Posted | March 29, 2003 |
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| Recall Status1 |
Terminated 3 on June 02, 2004 |
| Recall Number | Z-0691-03 |
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| 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
|
| 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 |
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| 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. |
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| 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
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