Device recall
Z-1086-2024: The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a…
FDA device recall · Class II · Quidel Corporation
Key facts
| Recall number (Z-number) | Z-1086-2024 |
|---|---|
| Recall event | 93799 |
| Product | The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocapsid protein from influenza A, influenza B, and SARS-CoV-2. This test allows for the detection of SARS-CoV and SARS-CoV-2, but does not differentiate between the… |
| Product code | QMN |
| Recalling firm | Quidel Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3021090658 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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