Device recall
Z-0001-2023: Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#…
FDA device recall · Class I · Jiangsu Well Biotech Co.,Ltd.
Key facts
| Recall number (Z-number) | Z-0001-2023 |
|---|---|
| Recall event | 90773 |
| Product | Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02 |
| Product code | QKP |
| Recalling firm | Jiangsu Well Biotech Co.,Ltd. |
| Recall class | Class I |
| Status | Open, Classified |
| FEI number | 3014719962 |
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