Device recall
Z-0441-2021: Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499
FDA device recall · Class III · Hardy Diagnostics
Key facts
| Recall number (Z-number) | Z-0441-2021 |
|---|---|
| Recall event | 86586 |
| Product | Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499 |
| Product code | PQZ |
| Recalling firm | Hardy Diagnostics |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 28, 2021 |
| 510(k) numbers | K170586 |
| FEI number | 2022807 |
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