Device recall
Z-1559-2026: Wondfo Streptococcal A At-Home Self-Test. At-home test for group A…
FDA device recall · Class II · Altruan GmbH
Key facts
| Recall number (Z-number) | Z-1559-2026 |
|---|---|
| Recall event | 98472 |
| Product | Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection. |
| Product code | GTY |
| Recalling firm | Altruan GmbH |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3042770115 |
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