Recall Z-0691-03 ยท 91
Abbott Health Products, Inc.
TDx/TDxFLx TDx/TDxFLX Tricyclic Antidepressant Reagent Distributed under the following label: TDx/TDxFLX, Abbott Laboratories USA, North Chicago, IL 60064
| Date | Mar 29, 2003 (initiated Dec 11, 2002) |
| Status | Terminated |
| Reason | Unexpected false positive TCA results |
| Root cause | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K853113 | TD TRICYCLIC ANTIDEPRESSANTS Abbott Laboratories, Aug 12, 1985 |