Device recall
Z-0124-2021: Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral…
FDA device recall · Class II · Quidel Corporation
Key facts
| Recall number (Z-number) | Z-0124-2021 |
|---|---|
| Recall event | 86276 |
| Product | Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab… |
| Product code | QKP |
| Recalling firm | Quidel Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 9, 2022 |
| FEI number | 2024674 |
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