Device recall
Z-0330-2023: Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST
FDA device recall · Class I · Remel Inc
Key facts
| Recall number (Z-number) | Z-0330-2023 |
|---|---|
| Recall event | 91104 |
| Product | Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST |
| Product code | JWY |
| Recalling firm | Remel Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Sep 30, 2024 |
| 510(k) numbers | K060621 |
| FEI number | 1924669 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 100–999 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