Device recall
Z-2031-2024: Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled…
FDA device recall · Class II · Wondfo USA Co Ltd
Key facts
| Recall number (Z-number) | Z-2031-2024 |
|---|---|
| Recall event | 94261 |
| Product | Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid Test, Part Number CD-STP25, b) Clarity Diagnostics LLC, Clarity Strep A Rapid Test, Part Number CD-STP25V |
| Product code | GTY |
| Recalling firm | Wondfo USA Co Ltd |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3007606081 |
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