Drug recall
Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich…
FDA recall event 86276 · Class II · Quidel Corporation
Key facts
| Event ID | 86276 |
|---|---|
| Recall numbers | Z-0124-2021 |
| Recalling firm | Quidel Corporation |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Instructions for use in the package insert for SARS Antigen FIA test were updated to remove all references to a specific viral transport medium product as well as the use of other viral transport… |
| Initiation date | Sep 17, 2020 |
| Report date | Oct 28, 2020 |
| Termination date | Aug 9, 2022 |
| City | San Diego |
| State | CA |
| Country | United States |
| FEI number | 2024674 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: