FDA-Device2026-03-18Class IIMISBRANDING
Wondfo Streptococcal A At-Home Self-Test recalled for lacking FDA clearance
What this means
Wondfo Streptococcal A At-Home Self-Test kits were distributed in the US without FDA clearance. This means the test's accuracy and safety have not been verified by the FDA. If you have this test, results may not be reliable.
- Stop using the test kit immediately
- Do not rely on results from this test for medical decisions
- Contact your healthcare provider if you think you have strep A
- Dispose of the kit safely or contact the manufacturer for return instructions
The agency's original wording
Hazard
Product not cleared by the FDA.
Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
188 units
Manufactured in
Morolding 6, N/A, Massing, N/A, Germany
Products
Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1559-2026Want us to check the next one for you?
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