Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
LuSys 2nd Generation of COVID-19 Viral Antigen Test For all Recalled by Lusys Laboratories, Inc. Due to COVID-19 test kits (Antibody Rapid Test kit and...
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 Lusys Laboratories, Inc. directly.
Affected Products
LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test)
Quantity: 14,745 kits
Why Was This Recalled?
COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Lusys Laboratories, Inc.
Lusys Laboratories, Inc. has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report