← FDA ENFORCEMENT
Z-2169-2026Class II
Quidel Corporation
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
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. 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. Open the enforcement explorer →