Quidel Corporation: Device Recall
Recall #Z-2545-2025 · 06/17/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2545-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Quidel Corporation
- Status
- Ongoing
- Date Initiated
- 06/17/2025
- Location
- San Diego, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22470
Reason for Recall
Dipstick strep A test has potential for false positive results.
Product Description
QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC
Distribution Pattern
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.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.