Device recall
Z-1312-2021: Coronavirus antigen detection test system - Product Usage: intended for the…
FDA device recall · Class II · LumiraDx
Key facts
| Recall number (Z-number) | Z-1312-2021 |
|---|---|
| Recall event | 87366 |
| Product | Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 directly from nasal swab samples collected from individuals suspected of COVID-19 by their healthcare provider within the first twelve days of symptom… |
| Product code | QKP |
| Recalling firm | LumiraDx |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 13, 2022 |
| FEI number | 3012642695 |
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