QUIDEL Sofia SARS Antigen FIA IVD REF 20374 — Class II medical device recall Z-0428-2021
Terminated recall by Quidel Corporation, reported 2020-11-18, distributed in AL, AR, AZ, CA, FL, GA, IN, LA…. Due to false positive results.
| Recall number | Z-0428-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Quidel Corporation, San Diego, CA, United States |
| Recall initiated | 2020-09-25 |
| Classified | 2020-11-06 |
| Reported by FDA | 2020-11-18 |
| Terminated | 2024-09-18 |
| Distributed | AL, AR, AZ, CA, FL, GA, IN, LA, MO, MS, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY |
| Quantity | 8,628 kits |
| UPC / GTIN / UDI-DI | 00014613339082 |
| Lot numbers | 706142 |
| Model numbers | 20374 |
Product
QUIDEL Sofia SARS Antigen FIA IVD REF 20374
Reason for recall
Due to false positive results.
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-0428-2021. 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.