← FDA ENFORCEMENT
Z-2169-2026Class II

Quidel Corporation

Recalling firm
Quidel Corporation
Product type
Device
Status
Ongoing
Report date
2026-05-20
Distribution
US Nationwide distribution in the states of AL, CA, FL, ID, IL, LA, MA, MD, MN, MO, NY, PA, SC, TN, TX, VA.
Firm state
CA
Product quantity
12279 units
Initiated by
Voluntary: Firm initiated
Reason for recall

Product has the potential for false positive results

Product description

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

Code / lot info

UDI/DI 30014613201083, Lot Numbers: 225788, 228322, 233274.

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.