FDA (Devices) recall action 98472
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
Product not cleared by the FDA.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Altruan GmbH is recalling the Wondfo Streptococcal A At-Home Self-Test, used for group A beta-hemolytic streptococcal infection, because the product is not cleared by the FDA.
Altruan GmbH is recalling the Clearest Strep-A Cassette Test, used to detect group A streptococci in throat swab samples, because the product is not cleared by the FDA.
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.