TDx/TDxFLx Opiates Reagent, Product list number: 9673-60
FDA device recall Z-1229-04 · posted 2004-07-28 · Terminated
Recall details
- Recalling firm
- Abbott Health Products, Inc.
- Reason for recall
- Abbott Diagnostics Division has found that the oxymorphone cross-reactivity information in the 'Specific Performance Characteristics' section of the TDx/TDxFLx Opiates Reagent package insert (commodity number 32-2087/R5) does not match the current product performance.
- Action taken
- A Device Correction Letter dated 5/28/04 was mailed to all customers. The letter explained the reason for the recall and provided specific instructions.
- Root cause
- Other
- Status
- Terminated
- Product code
- DJG
- Quantity affected
- 941 kits
- Distribution
- Distribution was to hospitals/laboratories
- Date initiated
- 2004-05-28
- Date posted
- 2004-07-28
- Date terminated
- 2004-09-10
- Location
- Barceloneta, PR
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REVISED LABELING FOR OPIATES (K874485) | Abbott Laboratories | 1987-11-23 |