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Altruan GmbH FDA Recalls
3 recalls on file across devices, 0 of them Class I and 3 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.Class IIDec 19, 2025Product not cleared by the FDA. |
| Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.Class IIDec 19, 2025Product not cleared by the FDA. |
| Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.Class IIDec 19, 2025Product not cleared by the FDA. |