ADx Tricyclic Antidepressants Reagent. Distributed under the following label: ADx, Abbott Laboratories USA, North Chicag
FDA device recall Z-0690-03 · posted 2003-03-29 · Terminated
Recall details
- Recalling firm
- Abbott Health Products, Inc.
- Reason for recall
- Unexpected false positive TCA results
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- 91
- 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, Tai
- Date initiated
- 2002-12-11
- Date posted
- 2003-03-29
- Date terminated
- 2004-06-02
- Location
- Barceloneta, PR
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REPORTING INTEGRATOR 3392A (K833113) | Hewlett-Packard Co. | 1983-11-21 |