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FDA DeviceClass IINotable

FDA Recall: Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat

Date: 2026-03-18
Brand: Altruan GmbH
Category: Medical Device
FDA Class: Class II

Description

Product not cleared by the FDA.

Hazard

Product not cleared by the FDA.

Remedy

188 units

View original recall →
FDA Recall: Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat | RecallWatch