Official recall notice
FDA DeviceClass IINotable
FDA Recall: Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat
- Recall date
- 2026-03-18
- Brand
- Altruan GmbH
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Product not cleared by the FDA.
Recommended action
What to do
188 units
Product description
Product not cleared by the FDA.