# FDA recall Z-0510-2021

> **VEO DIAGNOSTICS, LLC** · Class II · device recall initiated 2020-11-05.

## Product

ACCEL ELISA COVID-19 for the detection of total antibodies to SARS-CoV-2  Catalog AE301U    Kit lots: PXCOV073020, PXCOV081220  Expiration dates: January 18, 2021 and January 26, 2021

## Reason for recall

Emergency Use Authorization (EUA) removed from list of COVID-19 antibody tests

## Distribution

US Nationwide distribution including in the states of IA, PA, WA.

## Key facts

- **Recall number:** Z-0510-2021
- **Recalling firm:** VEO DIAGNOSTICS, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-05
- **Report date:** 2020-12-09
- **Termination date:** 2021-04-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Loveland, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0510-2021

## Citation

> AI Analytics. FDA recall Z-0510-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0510-2021. Source: US FDA. Licensed CC0.

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