FDA Enforcement
Class II
Ongoing
QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
Recall: Z-2169-2026
·
Reported May 20, 2026
Enforcement
- Recall Number
- Z-2169-2026
- Event ID
- 98709
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Quidel Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 20, 2026
- Initiation Date
- April 6, 2026
- Classification Date
- May 12, 2026
- Address
- 10165 McKellar Ct, San Diego, CA, 92121-4201, United States
Description
QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
Reason
Product has the potential for false positive results
Code Info
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.
Quantity
12279 units