Device recall
Z-0324-2023: CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200…
FDA device recall · Class II · GS Biomark LLC
Key facts
| Recall number (Z-number) | Z-0324-2023 |
|---|---|
| Recall event | 91032 |
| Product | CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200; BM-AD4K0200 BM-ADK0200 BM-CDK0200 BM-CFDK0200 BM-D4K0200 BM-DK0200 BM-DK0600 BM-DK0800 BM-DK1200 BM-DK1400 BM-DK1800 |
| Product code | QJR |
| Recalling firm | GS Biomark LLC |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3024479668 |
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