FDA Medical devices recall ·
QuickVue Dipstick Strep A Test, 50T recall
- Recall number
- Z-2169-2026
- Date
- (initiated April 6, 2026)
- Company / brand
- Quidel Corporation
10165 McKellar Ct, San Diego, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 12279 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
Why was it recalled?
Product has the 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
UDI/DI 30014613201083, Lot Numbers: 225788, 228322, 233274.
Distribution
US Nationwide distribution in the states of AL, CA, FL, ID, IL, LA, MA, MD, MN, MO, NY, PA, SC, TN, TX, VA.
States: Alabama California Florida Idaho Illinois Louisiana Massachusetts Maryland Minnesota Missouri New York Pennsylvania South Carolina Tennessee Texas Virginia
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-2169-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.