Device recall
Z-1594-2023: Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number…
FDA device recall · Class I · SD Biosensor, Inc.
Key facts
| Recall number (Z-number) | Z-1594-2023 |
|---|---|
| Recall event | 92137 |
| Product | Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728) |
| Product code | QKP |
| Recalling firm | SD Biosensor, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| FEI number | 3012133212 |
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