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

Medical DevicesSource: FDA (device) · Date: 2026-05-20

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Quidel Corporation
Product
QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
Reason / hazard
Product has the potential for false positive results
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of AL, CA, FL, ID, IL, LA, MA, MD, MN, MO, NY, PA, SC, TN, TX, VA.
Recall initiated
2026-04-06
Code info
UDI/DI 30014613201083, Lot Numbers: 225788, 228322, 233274.
Product quantity
12279 units
Voluntary mandated
Voluntary: Firm initiated
City
San Diego
State
CA
Country
United States
Event id
98709
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