FDA recall Z-2169-2026

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2026-04-06

Report date

2026-05-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2169-2026