Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Recalled by Universal Meditech Inc. Due to Distribution of SARS-CoV-2 Antigen Rapid Test Kits without...
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 Universal Meditech Inc. directly.
Affected Products
Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green and white box under the brand DiagnosUS, and, White box without brand name labeled as "SARS -COV-2 ANTIGEN DEVELOPMENT MADE IN USA ORAL SWAB TESTING
Quantity: 56,300 kits
Why Was This Recalled?
Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Authorization.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Universal Meditech Inc.
Universal Meditech Inc. has 28 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report