Skip to content
Recall Observatory FDA recall evidence

Device product

QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.

Z-2169-2026

April 06, 2026

Class II

Product summary

Firm
Quidel Corporation
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

    reason.no_named_rule · v1.0.0

    Product has the potential for false positive results