Bisaf Strep A Self-Test recalled for lack of FDA clearance
Altruan GmbH distributed Bisaf Strep A Self-Test kits without FDA clearance. This test is designed to detect group A streptococcal antigens in throat swabs, but has not been reviewed or approved by the FDA for safety and effectiveness. About 188 units were distributed nationwide.
From the FDA notice · Read the official notice ↗
What to do
- Stop using the Bisaf Strep A Self-Test immediately
- Do not rely on results from this test for medical decisions
- Contact your doctor for proper strep throat testing if you have symptoms
- If you have this test, contact the seller or Altruan GmbH for instructions on return or disposal
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 3 products — see all of them.
Details
- Units affected
- 188 units
- Illnesses reported
- None reported
- Manufactured in
- Morolding 6, N/A, Massing, N/A, Germany
- Classification
- Class II
- Recall number
- Z-1561-2026
In the FDA's words
- Description
- Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs. Product not cleared by the FDA. Model No. AL-42153; No UDI; Lot Code: 6952804827274. Distribution: US Nationwide distribution. Affected quantity: 188 units
- Hazard
- Product not cleared by the FDA.
3 products in this recall
Altruan Strep A tests recalled for lacking FDA clearance
Altruan is recalling three Strep A test products, including the Wondfo Streptococcal A At-Home Self-Test, Clearest Strep-A Cassette Test, and Bisaf Strep A Self-Test. The tests were distributed nationwide and the FDA has not cleared them. No injuries have been reported.
The agency lists each product separately. Check every one you might have.
- Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.Z-1559-2026 · 188 units
- Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.Z-1560-2026 · 188 units
- Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs. (this page)Z-1561-2026 · 188 units