QuickVue Dipstick Strep A Test recall (Quidel Corporation)
Medical deviceClass IIOngoing
Summary: Quidel Corporation is recalling QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.. Reason: Product has the potential for false positive results.
What is being recalled
QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
Why
Product has the potential for false positive results
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of AL, CA, FL, ID, IL, LA, MA, MD, MN, MO, NY, PA, SC, TN, TX, VA. (states named: Alabama, California, Florida, Idaho, Illinois, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, New York, Pennsylvania, South Carolina, Tennessee, Texas, Virginia)
How to tell if yours is affected
UDI/DI 30014613201083, Lot Numbers: 225788, 228322, 233274.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2169-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | April 6, 2026 |
| Reported | May 20, 2026 |
| Company | Quidel Corporation |
| Company location | San Diego, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 12279 units |
More recalls from Quidel Corporation · all medical device recalls · recalls from April 2026