FDA Medical devices recall ·
QuickVue: Dipstick Strep A Test: 50T recall
- Recall number
- Z-2545-2025
- Date
- (initiated June 17, 2025)
- Company / brand
- Quidel Corporation
10165 McKellar Ct, San Diego, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 22470
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC
Why was it recalled?
Dipstick strep A test has potential for false positive results.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
REF/UDI-DI/Lot(Expiration): 20108/30014613201083/709673(05-FEB-2026), 709676(05-FEB-2026), 709484(09-JAN-2026), 709501(09-JAN-2026), 709520(16-JAN-2026), 709535(16-JAN-2026); 20125/30014613201250/709487(09-JAN-2026), 709503(16-JAN-2026), 709509(16-JAN-2026), 709684(12-FEB-2026); 20108SC/0130014613330073/709485(09-JAN-2026), 709502(16-JAN-2026)
Distribution
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.
States: Alaska California Colorado Florida Idaho Illinois Kansas Louisiana Massachusetts Maryland Minnesota Missouri Mississippi North Carolina New Jersey New York Pennsylvania South Carolina Tennessee Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2545-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.