FDA-Device2025-09-17Class II
QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC
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-2545-2025More Quidel Corporation recalls
- FDA-Device2026-05-20Quidel QuickVue Dipstick Strep A Test recalled for false positive results
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