QuickVue Dipstick Strep A Test
Reason given by FDA: Product has the potential for false positive results.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Quidel Corporation of San Diego, California, recalled its QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp., because the product has the potential for false positive results. The company began the recall on April 6, 2026, and the FDA added it to the Enforcement Report on May 12, 2026.
The recall involved 12,279 units distributed in Alabama, California, Florida, Idaho, Illinois, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, New York, Pennsylvania, South Carolina, Tennessee, Texas, and Virginia.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and lot code listed under your product.
QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
- UDI-DI
- 30014613201083
- Lot
- 225788
- 228322
- 233274
Details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Alabama, California, Florida, Idaho, Illinois, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, New York, Pennsylvania, South Carolina, Tennessee, Texas, Virginia.
- Event ID
- 98709
- Recall No.
- Z-2169-2026
- Company
- Quidel CorporationSan Diego, California
- Hazard
- Device defect
- Quantity recalled
- 12279 units
- Recall type
- Voluntary: Firm initiated
- Customers told by
- Letter
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
