Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of 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
CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-CoV-2 Antigen Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals suspected of COVID-19 by their healthcare provider within five days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. (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