Device recall
Z-0404-03: Elan Diagnostics CHO ATAC Cholesterol Reagent Kit Product Number: 516-250
FDA device recall · Class III · Elan Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-0404-03 |
|---|---|
| Recall event | 25081 |
| Product | Elan Diagnostics CHO ATAC Cholesterol Reagent Kit Product Number: 516-250 |
| Product code | CHH |
| Recalling firm | Elan Diagnostics, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 15, 2012 |
| 510(k) numbers | K880237 |
| FEI number | 1221157 |
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