Versea Diagnostics recalls Healgen COVID-19 IgG/IgM Rapid Test Cassette for use outside certified labs. Products may be distributed to non-certified users, posing risks of inaccurate results.
Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorization.
Versea Diagnostics is recalling Healgen COVID-19 IgG/IgM Rapid Test Cassette kits because they may have been sold to non-laboratories. These tests are only meant for use by labs certified under CLIA regulations. Using them outside of certified labs could lead to inaccurate results.
The test is designed only for use by laboratories certified under CLIA regulations. If used outside of these certified labs, the results may be inaccurate, which could lead to incorrect health decisions.
Anyone who purchased the Healgen test cassette for home use. People who use these tests outside of CLIA-certified labs are most at risk of inaccurate results.
Look for Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) with the brand Versea Diagnostics. These products were distributed to customers outside of CLIA-certified laboratories.
Verify if your test cassette was purchased from a CLIA-certified laboratory. If not, stop using it immediately.
No, these tests are only intended for use by CLIA-certified laboratories. Home use is not approved.
Using the test outside of a CLIA-certified lab may lead to inaccurate results, which could affect health decisions.
The product was distributed to customers outside of CLIA-certified laboratories. Check if you purchased it from a lab that is not CLIA-certified.
We’ve drafted a message you can send Versea Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-2409-2021 — Versea Diagnostics Versea Diagnostics Hello, I own a Versea Diagnostics that is covered by recall Z-2409-2021 from Versea Diagnostics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
