Device product
QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
Z-2169-2026
Product summary
- Event
- Event 98709
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 12279 units
- Official record key
device-enforcement:Z-2169-2026
Official wording
Reason: Product has the potential for false positive results
Code information: UDI/DI 30014613201083, Lot Numbers: 225788, 228322, 233274.
Distribution pattern: US Nationwide distribution in the states of AL, CA, FL, ID, IL, LA, MA, MD, MN, MO, NY, PA, SC, TN, TX, VA.
Derived failure modes
-
Unknown
Product has the potential for false positive results