Device recall
Z-1274-2016: Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451…
FDA device recall · Class I · Focus Diagnostics Inc
Key facts
| Recall number (Z-number) | Z-1274-2016 |
|---|---|
| Recall event | 73283 |
| Product | Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2850, MOL1451, MOL1452, MOL1455 |
| Product code | PGX |
| Recalling firm | Focus Diagnostics Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jun 16, 2016 |
| 510(k) numbers | K143651 |
| FEI number | 2023365 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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