Drug recall
ACCEL ELISA COVID-19 for the detection of total antibodies to SARS-CoV-2 Catalog AE301U Kit lots: PXCOV073020…
FDA recall event 86798 · Class II · VEO DIAGNOSTICS, LLC
Key facts
| Event ID | 86798 |
|---|---|
| Recall numbers | Z-0510-2021 |
| Recalling firm | VEO DIAGNOSTICS, LLC |
| Product type | Devices |
| Products | 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 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Emergency Use Authorization (EUA) removed from list of COVID-19 antibody tests |
| Initiation date | Nov 5, 2020 |
| Report date | Dec 9, 2020 |
| Termination date | Apr 16, 2021 |
| City | Loveland |
| State | OH |
| Country | United States |
| FEI number | 3017223053 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: