FDA Device recall Z-0510-2021
ACCEL ELISA COVID-19 for the detection of total antibodies to SARS-CoV-2 Catalog AE301U Kit lots: PXCOV073020, PXCOV081220 Expiration dates…
- FDA Device
- Class II
- terminated
- Published 2020-12-09
On 2020-12-09 the FDA classified a Class II recall of ACCEL ELISA COVID-19 for the detection of total antibodies to SARS-CoV-2 Catalog AE301U Kit lots: PXCOV073020, PXCOV081220 Expiration dates… by Veo Diagnostics, citing emergency Use Authorization (EUA) removed from list of COVID-19 antibody tests.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0510-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-05 |
| Published | 2020-12-09 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Veo Diagnostics |
| Distribution | US |
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
Emergency Use Authorization (EUA) removed from list of COVID-19 antibody tests
Identifiers
| code_info | Kit lots: PXCOV073020, PXCOV081220 Expiration dates: January 18, 2021 and January 26, 2021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0510-2021%22
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