Device recall
Z-0510-2021: ACCEL ELISA COVID-19 for the detection of total antibodies to SARS-CoV-2 Catalog…
FDA device recall · Class II · VEO DIAGNOSTICS, LLC
Key facts
| Recall number (Z-number) | Z-0510-2021 |
|---|---|
| Recall event | 86798 |
| 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 |
| Product code | QMN |
| Recalling firm | VEO DIAGNOSTICS, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 16, 2021 |
| FEI number | 3017223053 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database