Recall Z-1561-2026 ยท GTY Antigens, All Groups, Streptococcus Spp.
Altruan GmbH
Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
| Date | Mar 12, 2026 (initiated Dec 19, 2025) |
| Status | Open, Classified |
| Reason | Product not cleared by the FDA. |
| Root cause | No Marketing Application |
| Action | The firm distributed a Recall Notice via email to consignees who purchased affected devices from Altruan's website. The notice instructs consignees to immediately stop using recalled devices and to destroy/dispose of devices in consignee possession. Consignees are to reply to Altruan's email with their order number and confirmation of product disposal to receive a refund. |
| Quantity | 188 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.