Recall Z-1229-04 ยท DJG Enzyme Immunoassay, Opiates
Abbott Health Products, Inc.
TDx/TDxFLx Opiates Reagent, Product list number: 9673-60
| Date | Jul 28, 2004 (initiated May 28, 2004) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 941 kits |
| Distribution | Distribution was to hospitals/laboratories |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K874485 | REVISED LABELING FOR OPIATES Abbott Laboratories, Nov 23, 1987 |