VEO Diagnostics ACCEL ELISA COVID-19 Kit Recalled Due to EUA Removal
VEO Diagnostics recalls ACCEL ELISA COVID-19 antibody test kits (AE301U, lots PXCOV073020 and PXCOV081220) after FDA emergency use authorization was removed.
Lower-risk recall
Emergency Use Authorization (EUA) removed from list of COVID-19 antibody tests
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/63982-veo-diagnostics-accel-elisa-covid-19-kit-recalled-due-to.
Source Summary by GovInfoNow · govinfonow.com/recall/63982-veo-diagnostics-accel-elisa-covid-19-kit-recalled-due-to · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0510-2021
Cite this page
“VEO Diagnostics ACCEL ELISA COVID-19 Kit Recalled Due to EUA Removal.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63982-veo-diagnostics-accel-elisa-covid-19-kit-recalled-due-to. Based on FDA recall #Z-0510-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0510-2021%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
VEO Diagnostics- Category
Medical device
What to do — step by step
Check Kit Lot Number
Look for lot numbers PXCOV073020 or PXCOV081220 on the packaging to confirm if the kit is recalled.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 3 states.
FDA distribution: “US Nationwide distribution including in the states of IA, PA, WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Iowa, Pennsylvania, Washington.
Recall timeline
FDA terminated this recall 5 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using this kit?
No, but the results may be inaccurate. If you used this kit, consider retesting with a different kit.
What should I do if I have this 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.
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Where this comes from
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.
- Official source: FDA Recall #Z-0510-2021 (November 5, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0510-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.