Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Recalled by INNOVA MEDICAL GROUP, INC. Due to Due to distributing test kits to customers who...
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 INNOVA MEDICAL GROUP, INC. directly.
Affected Products
For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT1309
Quantity: 1,945 boxes (=48,625 individual tests)
Why Was This Recalled?
Due to distributing test kits to customers who were not part of a clinical investigation.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About INNOVA MEDICAL GROUP, INC.
INNOVA MEDICAL GROUP, INC. has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report