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

Recall date

June 17, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2545-2025

FDA classification

Class II

Brand / firm

Quidel Corporation

Sold / distributed

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.

Why it was recalled

Dipstick strep A test has potential for false positive results.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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