Device recall
Z-2407-2021: CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-CoV-2…
FDA device recall · Class II · Versea Diagnostics LLC
Key facts
| Recall number (Z-number) | Z-2407-2021 |
|---|---|
| Recall event | 88429 |
| Product | CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-CoV-2 Antigen Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals suspected of COVID-19 by their healthcare provider… |
| Product code | QKP |
| Recalling firm | Versea Diagnostics LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 10, 2024 |
| FEI number | 3019891938 |
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