QuickVue Dipstick Strep A Test — Class II medical device recall Z-2169-2026
Ongoing recall by Quidel Corporation, reported 2026-05-20, distributed nationwide. Product has the potential for false positive results
| Recall number | Z-2169-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Quidel Corporation, San Diego, CA, United States |
| Recall initiated | 2026-04-06 |
| Classified | 2026-05-12 |
| Reported by FDA | 2026-05-20 |
| Distributed | Nationwide (US) |
| Quantity | 12,279 units |
| UPC / GTIN / UDI-DI | 30014613201083 |
| Lot numbers | 225788, 228322, 233274 |
| Model numbers | 20108 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2169-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.