FDA-Device2026-03-18Class IIMISBRANDING
Bisaf Strep A Self-Test recalled — not FDA-cleared for use
FALSE CLAIMSNationwide distribution
Stop using Bisaf Strep A Self-Test
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.
- 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
Hazard
Product not cleared by the FDA.
Sold states
US Nationwide distribution.
Affected count
188 units
Manufactured in
Morolding 6, N/A, Massing, N/A, Germany
Products
Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1561-2026Don't want to check this manually?
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