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U.S. Department of Health and Human Services

Medical Device Recalls
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Related Medical Device Recalls
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Z-1559-2026 - Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection. 2 03/12/2026 FEI # 3042770115
Altruan GmbH
Z-1561-2026 - Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs. 2 03/12/2026 FEI # 3042770115
Altruan GmbH
Z-1560-2026 - Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples. 2 03/12/2026 FEI # 3042770115
Altruan GmbH
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