Device recall
Z-0135-2023: LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #…
FDA device recall · Class III · LumiraDx
Key facts
| Recall number (Z-number) | Z-0135-2023 |
|---|---|
| Recall event | 90998 |
| Product | LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip. The Quality Controls provide… |
| Product code | QKP |
| Recalling firm | LumiraDx |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 13, 2024 |
| 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