Versea recalls CareStart COVID-19 antigen tests for use outside certified labs. Tests may be distributed to non-CLIA labs, risking inaccurate results. Consumers should check lot numbers and contact Versea for details.
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 is recalling CareStart COVID-19 antigen tests because they might be used outside of labs approved by the FDA. This could lead to inaccurate test results if used improperly.
The tests are designed for use only in labs approved under CLIA regulations. If used outside these labs, the results may be inaccurate, leading to incorrect health decisions.
Healthcare providers and consumers who used these tests outside of FDA-certified labs. Those testing at home without proper guidance are at higher risk of inaccurate results.
The CareStart COVID-19 Antigen Rapid Diagnostic Test. Check the lot number on the packaging to confirm it's part of this recall. All lot codes are affected.
Look for the lot number on the test packaging to confirm it's part of this recall.
The tests may have been distributed to customers other than laboratories certified under CLIA regulations, which could lead to inaccurate results.
No, but you should check the lot number to confirm if it's part of this recall. If it is, contact Versea for further instructions.
Check the lot number on the test packaging. All lot codes are affected by this recall.
We’ve drafted a message you can send Versea to request your refund or repair — edit it as you like.
Subject: Recall Z-2407-2021 — Versea Versea Hello, I own a Versea that is covered by recall Z-2407-2021 from Versea. 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.
