Device recall
Z-0944-2022: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID…
FDA device recall · Class I · SML Distribution, LLC
Key facts
| Recall number (Z-number) | Z-0944-2022 |
|---|---|
| Recall event | 89975 |
| Product | Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test |
| Product code | QKP |
| Recalling firm | SML Distribution, LLC |
| Recall class | Class I |
| Status | Open, Classified |
| FEI number | 3022161362 |
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