Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis Recalled by Versea Diagnostics LLC Due to Products may have been distributed to customers other...
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 Versea Diagnostics LLC directly.
Affected Products
Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenzas Type A, and Type B Antigens Simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A and influenza B directly from nasopharyngeal swab specimens obtained from individuals, who are suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider, within the first five days of onset of symptoms. Emergency use of this test is limited to authorized laboratories. (CLIA Waived Laboratories)
Quantity: 563,290 in total
Why Was This Recalled?
Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorization.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Versea Diagnostics LLC
Versea Diagnostics LLC has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report