Device recall
Z-1056-2007: TDx/TDxFLx Methotrexate II Reagent-List Number 07A12-60 - a reagent system for…
FDA device recall · Class III · Abbott Diagnostic International, Ltd.
Key facts
| Recall number (Z-number) | Z-1056-2007 |
|---|---|
| Recall event | 37728 |
| Product | TDx/TDxFLx Methotrexate II Reagent-List Number 07A12-60 - a reagent system for In Vitro diagnostic use. This reagent system is composed of one bottle of Wash Solution, one bottle of Methotrexate Antibody, one bottle of Methotrexate Fluorescein Tracer and one bottle of Pretreatment Solution. |
| Product code | LAO |
| Recalling firm | Abbott Diagnostic International, Ltd. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 10, 2011 |
| 510(k) numbers | K932615 |
| FEI number | 2623532 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database