Altruan
3 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Altruan and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-03-18FDA-DeviceClass IIStop 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.
- 2026-03-18FDA-DeviceClass IIStop using Altruan Strep-A test kits
Altruan GmbH distributed Clearest Strep-A Cassette Test kits that were not cleared or approved by the FDA before being sold. These tests are designed to detect group A streptococci (Strep A) in throat swab samples. About 188 units were distributed nationwide.
- 2026-03-18FDA-DeviceClass IIStop using Wondfo Strep A home test kit
Wondfo Streptococcal A At-Home Self-Test kits were distributed in the US without FDA clearance. This means the test's accuracy and safety have not been verified by the FDA. If you have this test, results may not be reliable.
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