Device recall
Z-2095-2015: Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Alere"…
FDA device recall · Class II · Alere Scarborough, Inc. dba Binax, Inc.
Key facts
| Recall number (Z-number) | Z-2095-2015 |
|---|---|
| Recall event | 71585 |
| Product | Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Alere" i Influenza A & B assay, performed on the Alere" i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination… |
| Product code | OCC |
| Recalling firm | Alere Scarborough, Inc. dba Binax, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 15, 2015 |
| 510(k) numbers | K141520 |
| FEI number | 1221359 |
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