VEO Diagnostics recalls ACCEL ELISA COVID-19 antibody test kits (AE301U, lots PXCOV073020 and PXCOV081220) after FDA emergency use authorization was removed.
Emergency Use Authorization (EUA) removed from list of COVID-19 antibody tests
VEO Diagnostics is recalling specific COVID-19 antibody test kits because the FDA removed them from emergency use authorization. This means the tests may not be reliable for detecting SARS-CoV-2 antibodies.
The FDA removed these kits from emergency use authorization, meaning they no longer meet the required standards for reliable COVID-19 antibody testing. This could lead to false negative or positive results if used for testing.
People who purchased the ACCEL ELISA COVID-19 antibody test kits (AE301U) with lot numbers PXCOV073020 or PXCOV081220 between January 2020 and January 2021 are affected. Those using these kits for testing are most at risk of inaccurate results.
Check for the product name 'ACCEL ELISA COVID-19' with catalog number AE301U. Look for lot numbers PXCOV073020 or PXCOV081220 on the packaging. These kits expired by January 2021.
Look for lot numbers PXCOV073020 or PXCOV081220 on the packaging to confirm if the kit is recalled.
The FDA removed these kits from emergency use authorization, meaning they no longer meet the required standards for reliable COVID-19 antibody testing.
No, but the results may be inaccurate. If you used this kit, consider retesting with a different kit.
Check the lot number to see if it's recalled. If it is, you may not need to take action since the kit is no longer authorized, but results could be unreliable.
We’ve drafted a message you can send VEO Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-0510-2021 — VEO Diagnostics VEO Diagnostics Hello, I own a VEO Diagnostics that is covered by recall Z-0510-2021 from VEO 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.
