Versea Diagnostics recalls FaStep COVID-19 IgG/IgM tests for unapproved lab use. Products may be used outside certified labs, risking inaccurate results. No remedy specified.
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 FaStep COVID-19 IgG/IgM Rapid Test Device because it may have been distributed to customers outside of certified laboratories. This could lead to inaccurate test results if used improperly.
The tests are designed for use only in labs certified under CLIA regulations. If used outside these certified labs, the results may be inaccurate, potentially leading to incorrect health decisions.
Anyone who purchased the FaStep test device. People using it outside of CLIA-certified labs are most at risk of inaccurate results.
The FaStep COVID-19 IgG/IgM Rapid Test Device. All lot codes are affected. The product is intended for use in CLIA-certified laboratories only.
Verify if your test was used in a CLIA-certified laboratory. If not, the product may be unsafe.
The product is intended for use only in CLIA-certified laboratories. If used outside these labs, results may be inaccurate.
No remedy is specified in the recall notice.
The FaStep COVID-19 IgG/IgM Rapid Test Device with all lot codes is affected.
We’ve drafted a message you can send Versea Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-2408-2021 — Versea Diagnostics Versea Diagnostics Hello, I own a Versea Diagnostics that is covered by recall Z-2408-2021 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.
