Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Clarity and Clarity Diagnostics LLC Recalled by Wondfo USA Co Ltd Due to Wondfo USA has identified unauthorized distribution of the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Wondfo USA Co Ltd directly.
Affected Products
Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid Test, Part Number CD-STP25, b) Clarity Diagnostics LLC, Clarity Strep A Rapid Test, Part Number CD-STP25V
Quantity: 170,000 units
Why Was This Recalled?
Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Wondfo USA Co Ltd
Wondfo USA Co Ltd has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report