FDA DevicesClass II
QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococ...
Published: May 20, 2026Recall ID: Z-2169-2026Category: devicesCountry: US
Reason for Recall / Hazard
Product has the potential for false positive results
Product Description & Identification
QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
Additional Source Details
| Field | Value |
|---|---|
| City | San Diego |
| State | CA |
| Event id | 98709 |
| Address 1 | 10165 McKellar Ct |
| Code info | UDI/DI 30014613201083, Lot Numbers: 225788, 228322, 233274. |
| Postal code | 92121-4201 |
| Report date | 20260520 |
| Product type | Devices |
| Product quantity | 12279 units |
| Reason for recall | Product has the potential for false positive results |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260406 |
| Initial firm notification | Letter |
| Center classification date | 20260512 |
Overview
- Recalling FirmQuidel Corporation
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of AL, CA, FL, ID, IL, LA, MA, MD, MN, MO, NY, PA, SC, TN, TX, VA.