FDA-Device2020-11-18Class II
QUIDEL Sofia SARS Antigen FIA IVD REF 20374
Quidel Corporation
Hazard
Due to false positive results.
Sold states
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
Affected count
8,628 kits
Manufactured in
10165 McKellar Ct, San Diego, CA, United States
Products
QUIDEL Sofia SARS Antigen FIA IVD REF 20374
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0428-2021Don't want to check this manually?
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