Preview Strep A — Class II medical device recall Z-2030-2024
Ongoing recall by Wondfo USA Co Ltd, reported 2024-06-19, distributed nationwide. Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution
| Recall number | Z-2030-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Wondfo USA Co Ltd, Willowbrook, IL, United States |
| Recall initiated | 2024-04-22 |
| Classified | 2024-06-07 |
| Reported by FDA | 2024-06-19 |
| Distributed | Nationwide (US) |
| Quantity | 1,238,755 units |
| Lot numbers | W03910902, W03910911, W03911002, W03920804, W03920902, W03921005, W03921008, W03921102, W03921103, W039212001, W039212006, W039301003, W039301004, W039301005, W039306008, W039307002, W039309003, W039309007, W03931002 |
Product
Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10
Reason for recall
Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.
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-2030-2024. 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.