FDA Device recall Z-0428-2021
QUIDEL Sofia SARS Antigen FIA IVD REF 20374
- FDA Device
- Class II
- terminated
- Published 2020-11-18
On 2020-11-18 the FDA classified a Class II recall of QUIDEL Sofia SARS Antigen FIA IVD REF 20374 by Quidel, citing due to false positive results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0428-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-09-25 |
| Published | 2020-11-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Quidel |
| Distribution | AL, AR, AZ, CA, FL, GA, IN, LA, MO, MS, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY |
Product
QUIDEL Sofia SARS Antigen FIA IVD REF 20374
Reason
Due to false positive results.
Identifiers
| code_info | Model Number 20374 Lot Number: 706142 UPC A GTIN-12: 0 14613 33908 2 Cassettes: 168365 through 166817 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0428-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.