Clarity and Clarity Diagnostics LLC — Class II medical device recall Z-2031-2024
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-2031-2024 |
|---|---|
| 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 | 170,000 units |
| Lot numbers | CD-STP25V, W03920402, W03920404, W03920603, W03920707, W03921002, W03921006, W039301001, W039302001, W039302002, W039302003, W039306003 |
| Model numbers | CD-STP25, CD-STP25V |
Product
Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid Test, Part Number CD-STP25, b) Clarity Diagnostics LLC, Clarity Strep A Rapid Test, Part Number CD-STP25V
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-2031-2024. 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.