Device recall
Z-0426-2021: EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit…
FDA device recall · Class II · Epitope Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-0426-2021 |
|---|---|
| Recall event | 86516 |
| Product | EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is intended for qualitative detection of human anti-COVID-19 IgG antibody in human serum. This kit is to be used as an aid for the detection of novel COVID-19. Patients with suspected clustering cases require diagnosis or… |
| Product code | QKO |
| Recalling firm | Epitope Diagnostics, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3004185580 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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