The Food and Drug Administration (FDA) has issued a Class II recall for the Bisaf Strep A Self-Test, identified by recall number Z-1561-2026. The reason for the recall is that the product has not received clearance from the FDA. This action impacts the nationwide distribution of the test, which is intended for the detection of group A streptococcal antigens in throat swabs.

Manufacturers and distributors of this device must cease distribution and comply with FDA recall procedures. Healthcare providers who may have distributed or used this test should be aware of the recall and consider alternative testing methods. While the document does not specify a compliance deadline, the nature of a recall implies immediate action is required to remove the product from the market and notify affected parties.