Bisaf Strep A self-test recalled because it lacks FDA clearance
Altruan GmbH is recalling the Bisaf Strep A Self-Test, used to detect group A streptococcal antigens in throat swabs, because the product is not cleared by the FDA.
- Product
- Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
- Category
- Medical Device
- Distribution
- Distributed nationwide