Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
visby medical COVID-19 Test kit *** An in vitro diagnostic Recalled by VISBY MEDICAL INC Due to Two issues: 1) 5 Lots were found to...
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 VISBY MEDICAL INC directly.
Affected Products
visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative detection of SARS-CoV-2 - Product Usage: The Visby Medical COVID-19 Test is only for use under the Food and Drug Administration s Emergency Use Authorization.
Quantity: Total = 282 kits
Why Was This Recalled?
Two issues: 1) 5 Lots were found to have incorrect labeling on the outer box stating that the product is CLIA Waived. 2) 3 Lots contain a kit component that expires prior to the expiration date on the test kits.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About VISBY MEDICAL INC
VISBY MEDICAL 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