QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC
Reported: September 17, 2025 Initiated: June 17, 2025 #Z-2545-2025
Product Description
QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC
Reason for Recall
Dipstick strep A test has potential for false positive results.
Details
- Recalling Firm
- Quidel Corporation
- Units Affected
- 22470
- 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.
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC. Recalled by Quidel Corporation. Units affected: 22470.
Why was this product recalled? ▼
Dipstick strep A test has potential for false positive results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 17, 2025. Severity: Moderate. Recall number: Z-2545-2025.
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