Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a… — Class II medical device recall Z-0124-2021
Terminated recall by Quidel Corporation, reported 2020-10-28, distributed nationwide. Instructions for use in the package insert for SARS Antigen FIA test were updated to remove all references to
| Recall number | Z-0124-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Quidel Corporation, San Diego, CA, United States |
| Recall initiated | 2020-09-17 |
| Classified | 2020-10-19 |
| Reported by FDA | 2020-10-28 |
| Terminated | 2022-08-09 |
| Distributed | Nationwide (US) |
| Quantity | 10,537 |
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 specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms.
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 media. Use of the specific viral transport medium products may result in False-positive results. Directly testing from specimens (NS or NP swab) is recommended.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0124-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.