United StatesWondfo Streptococcal A At-Home Self-Test and similar at-home group A streptococcal antigen tests marketed as Clearest Strep‑A Cassette Test and Bisaf Strep A Self‑Test (Model No. 41972, Lot 6933289812337; Model No. SP‑C310343‑10, Lot 01242573; Model No. AL‑42153, Lot 6952804827274) sold nationwide in the U.S. are affected. Altruan GmbH is recalling 188 units because the products are not cleared by the U.S. Food and Drug Administration.
What's being recalled
Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.
Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.
Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
Recalling firm: Altruan GmbH, Massing, N/A, Germany.
How to identify it
Model No. 41972; No UDI; Lot Code: 6933289812337. Model No. SP-C310343-10; No UDI; Lot Code: 01242573. Model No. AL-42153; No UDI; Lot Code: 6952804827274.
The hazard
Product not cleared by the FDA.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)