FDA-Device2025-09-17Class II

QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC

Quidel Corporation
Hazard

Dipstick strep A test has potential for false positive results.

Sold states
Worldwide - US Nationwide distribution in the states of MA, NJ, MD, NC, SC, FL, TN, MS, MN, IL, MO, KS, LA, TX, CO, ID, CA, AK, NY, PA and the countries of Canada, Italy, Denmark, Norway, Sweden, Finland, Thailand, Israel, Slovenia, Turkey.
Affected count
22470
Manufactured in
10165 McKellar Ct, N/A, San Diego, CA, United States
Products
QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2545-2025

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