Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
E25Bio COVID-19 Direct Antigen Rapid Test Recalled by E25Bio, Inc. Due to The Test is not authorized, cleared, or approved...
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 E25Bio, Inc. directly.
Affected Products
E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit
Quantity: 73,300 units
Why Was This Recalled?
The Test is not authorized, cleared, or approved by FDA for clinical diagnostic or screening purposes. It was distributed without sufficient directions or controls in place.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About E25Bio, Inc.
E25Bio, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report