Device recall
Z-1540-2014: Alere Triage BNP Test for the Beckman Coulter Access Family of Immunoassay…
FDA device recall · Class II · Alere San Diego, Inc.
Key facts
| Recall number (Z-number) | Z-1540-2014 |
|---|---|
| Recall event | 67910 |
| Product | Alere Triage BNP Test for the Beckman Coulter Access Family of Immunoassay Systems, Model Number 98200, Lot Numbers: 329599, 331265. The Alere Triage BNP test is intended to be used as an aid in the diagnosis of congestive heart failure (heart failure), as an aid in the assessment of severity of… |
| Product code | NBC |
| Recalling firm | Alere San Diego, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 23, 2015 |
| 510(k) numbers | K052789 |
| 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