Device recall
Z-1132-2021: LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe…
FDA device recall · Class II · LumiraDx
Key facts
| Recall number (Z-number) | Z-1132-2021 |
|---|---|
| Recall event | 87259 |
| Product | LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test Strips, Catalog #:L016000109048. Part of the LumiraDx Platform, a point of care system for professional use for in vitro diagnostic tests. It comprises a portable… |
| Product code | QKP |
| Recalling firm | LumiraDx |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 3, 2021 |
| 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