FDADecember 19, 2025device
Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Product not cleared by the FDA.
What to do
FDA enforcement status: Ongoing
Brands named
altruan
UPCs
6952804827274
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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