Device recall
Z-0719-2022: STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid…
FDA device recall · Class I · SD Biosensor, Inc.
Key facts
| Recall number (Z-number) | Z-0719-2022 |
|---|---|
| Recall event | 89527 |
| Product | STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample. |
| 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