Device recall
Z-1561-2026: Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal…
FDA device recall · Class II · Altruan GmbH
Key facts
| Recall number (Z-number) | Z-1561-2026 |
|---|---|
| Recall event | 98472 |
| Product | Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs. |
| 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