FDA-Device2026-05-20Class IIPROCESSING DEFECT
Quidel QuickVue Dipstick Strep A Test recalled for false positive results
What this means
Certain lots of the Quidel QuickVue Dipstick Strep A Test may return false positive results, meaning the test could indicate a strep infection when one is not actually present. This could lead to unnecessary antibiotic treatment. The recall affects specific lot numbers distributed across the US.
- Check if your test kit is from lot 225788, 228322, or 233274 (printed on the box).
- If you have an affected lot, do not use it. Contact your healthcare provider or Quidel for a replacement.
- If you used an affected test and received a positive result, confirm the diagnosis with your doctor before starting antibiotics.
The agency's original wording
Hazard
Product has the potential for false positive results
Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of AL, CA, FL, ID, IL, LA, MA, MD, MN, MO, NY, PA, SC, TN, TX, VA.
Affected count
12279 units
Manufactured in
10165 McKellar Ct, San Diego, CA, United States
Products
QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2169-2026Want us to check the next one for you?
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