QuickVue: Dipstick Strep A Test: 50T — Class II medical device recall Z-2545-2025
Ongoing recall by Quidel Corporation, reported 2025-09-17, distributed nationwide. Dipstick strep A test has potential for false positive results.
| Recall number | Z-2545-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Quidel Corporation, San Diego, CA, United States |
| Recall initiated | 2025-06-17 |
| Classified | 2025-09-10 |
| Reported by FDA | 2025-09-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, DK, FI, IL, IT, NO, SE, SI, TH, TR |
| Quantity | 22,470 |
| UPC / GTIN / UDI-DI | 30014613201083, 30014613201250 |
| Model numbers | 20108, 20108SC, 20125 |
Product
QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC
Reason for recall
Dipstick strep A test has 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-2545-2025. 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.