Device recall
Z-1958-2014: Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413 Simplexa"…
FDA device recall · Class II · Focus Diagnostics Inc
Key facts
| Recall number (Z-number) | Z-1958-2014 |
|---|---|
| Recall event | 68347 |
| Product | Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413 Simplexa" Flu A/B & RSV Direct. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus… |
| Product code | OCC |
| Recalling firm | Focus Diagnostics Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 31, 2014 |
| 510(k) numbers | K120413 |
| FEI number | 2023365 |
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