Class II
Medical Device Recall: QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
Quidel Corporation · April 6, 2026
Reason for Recall
Product has the potential for false positive results
Distribution
US Nationwide distribution in the states of AL, CA, FL, ID, IL, LA, MA, MD, MN, MO, NY, PA, SC, TN, TX, VA.
States Affected
NATIONWIDE
Quantity Affected
12279 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2169-2026
Status: ongoing
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