Device recall
Z-2059-2008: ABBOTT Clinical Chemistry Phenytoin, List Number: 1E07-20, is used for the…
FDA device recall · Class II · Abbott Laboratories Inc.
Key facts
| Recall number (Z-number) | Z-2059-2008 |
|---|---|
| Recall event | 48173 |
| Product | ABBOTT Clinical Chemistry Phenytoin, List Number: 1E07-20, is used for the quantitation of phenytoin in human serum or plasma. |
| Product code | DIP |
| Recalling firm | Abbott Laboratories Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 23, 2012 |
| 510(k) numbers | K993026 |
| FEI number | 2018433 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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