Device recall
Z-1401-2022: SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral…
FDA device recall · Class I · North American Diagnostics
Key facts
| Recall number (Z-number) | Z-1401-2022 |
|---|---|
| Recall event | 90381 |
| Product | SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML LDT Kits, SML Brand Finished Kits, SML Brand BT Test Kits, SML Brand BT Antigen Test Kit LDT |
| Product code | QKP |
| Recalling firm | North American Diagnostics |
| Recall class | Class I |
| Status | Open, Classified |
| FEI number | 3021477751 |
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