Versea Diagnostics recalls its COVID-19/flu rapid test kits that may have been sold to non-certified labs. These tests are only approved for use in CLIA-certified laboratories. Consumers should not use these kits outside of authorized labs.
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 its COVID-19 and flu rapid test kits because they were distributed to labs that aren't certified under CLIA rules. This means the tests could give inaccurate results if used outside of authorized laboratories.
These rapid tests are designed only for use in laboratories certified under CLIA rules. If used outside of these certified labs, the tests may not work properly and could lead to incorrect health decisions.
Healthcare providers and labs that aren't CLIA-certified may have received these tests. Individuals using the kits at home or in non-certified settings are at risk of inaccurate results.
Check the product label for the name 'Status COVID-19/Flu Rapid Immunoassay'. The tests were distributed to labs without CLIA certification, so they might be in non-certified labs or sold to consumers.
Verify if your lab is CLIA-certified before using the test. If not, stop using the test.
No, these tests are only approved for use in CLIA-certified laboratories. Home use is not recommended.
The tests may have been distributed to labs that aren't certified under CLIA rules, which could lead to inaccurate results.
The recall does not require returning the test. However, if you used it in a non-certified lab, you should not use it again.
We’ve drafted a message you can send Versea Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-2410-2021 — Versea Diagnostics Versea Diagnostics Hello, I own a Versea Diagnostics that is covered by recall Z-2410-2021 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.
