Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
FDA device recall Z-1561-2026 · posted 2026-03-12 · Open, Classified
Recall details
- Recalling firm
- Altruan GmbH
- Reason for recall
- Product not cleared by the FDA.
- Action taken
- 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.
- Root cause
- No Marketing Application
- Status
- Open, Classified
- Product code
- GTY
- Quantity affected
- 188 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2025-12-19
- Date posted
- 2026-03-12
- Location
- Massing, Germany
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