FDAFDA · Food and drugs·Recall number Z-2169-2026
QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
Published May 20, 2026 · Recall initiated: April 6, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Product has the potential for false positive results
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Quidel Corporation
- Distributor
- US Nationwide distribution in the states of AL, CA, FL, ID, IL, LA, MA, MD, MN, MO, NY, PA, SC, TN, TX, VA.
- Lot
- UDI/DI 30014613201083, Lot Numbers: 225788, 228322, 233274.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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