Device recall
Z-2153-2023: Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct…
FDA device recall · Class II · DiaSorin Molecular LLC
Key facts
| Recall number (Z-number) | Z-2153-2023 |
|---|---|
| Recall event | 92559 |
| Product | Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct Amplification Discs (DADs). Each box contains discs individually pouch-sealed and labeled with REF: MOL1452 |
| Product code | OOI |
| Recalling firm | DiaSorin Molecular LLC |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 2023365 |
At a glance
- None 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