Device recall
Z-1467-2012: Alere Triage Profiler SOB Panel, PN 97300. The test is used as an aid in the…
FDA device recall · Class II · Alere San Diego
Key facts
| Recall number (Z-number) | Z-1467-2012 |
|---|---|
| Recall event | 61516 |
| Product | Alere Triage Profiler SOB Panel, PN 97300. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of heart failure, an aid in the risk stratification of patients with heart failure, an aid in the assessment and evaluation of… |
| Product code | MMI |
| Recalling firm | Alere San Diego |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 4, 2012 |
| 510(k) numbers | K080269 |
| FEI number | 1000125596 |
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