ACCEL ELISA COVID-19 for the detection of total antibodies to… — Class II medical device recall Z-0510-2021
Terminated recall by VEO DIAGNOSTICS, LLC, reported 2020-12-09, distributed nationwide. Emergency Use Authorization (EUA) removed from list of COVID-19 antibody tests
| Recall number | Z-0510-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | VEO DIAGNOSTICS, LLC, Loveland, OH, United States |
| Recall initiated | 2020-11-05 |
| Classified | 2020-12-01 |
| Reported by FDA | 2020-12-09 |
| Terminated | 2021-04-16 |
| Distributed | Nationwide (US) |
| Quantity | 15 kits |
| Lot numbers | PXCOV073020, PXCOV081220 |
| Model numbers | AE301U, PXCOV073020, PXCOV081220 |
| Expiration dates | 2021-01-18 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0510-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.