FDA recall Z-0428-2021

Product

QUIDEL Sofia SARS Antigen FIA IVD REF 20374

Reason for recall

Due to false positive results.

Distribution

U.S.: AL, AR, AZ, CA, FL, GA, IN, LA, MO, MS, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY

Key facts

Status

Terminated

Initiation date

2020-09-25

Report date

2020-11-18

Termination date

2024-09-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0428-2021