FDA Recall
Open, Classified
Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
Recall: Z-1561-2026
·
Initiated December 19, 2025
Recall
- Recall Number
- Z-1561-2026
- Event Number
- 98472
- Firm
- Altruan GmbH Morolding 6 Massing Germany
- FEI Number
- 3042770115
- Product Code
- GTY
- Status
- Open, Classified
- Root Cause
- No Marketing Application
- Initiated
- December 19, 2025
- Posted
- March 12, 2026
Description
Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
Reason
Product not cleared by the FDA.
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.
Distribution
US Nationwide distribution.
Quantity
188 units