Wondfo USA Co Ltd
Wondfo USA Co Ltd appears in FDA public data with 5 recalls, 2 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-2033-2024, Class II) was initiated on April 22, 2024. Its most recent 510(k) clearance was granted on August 20, 2025.
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 2
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2033-2024 | Class II | Independent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: IMCO Strep A Rapid Tes | April 22, 2024 |
| Z-2034-2024 | Class II | Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondView Strep A Test Kit, Gu | April 22, 2024 |
| Z-2031-2024 | Class II | Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep | April 22, 2024 |
| Z-2030-2024 | Class II | Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10 | April 22, 2024 |
| Z-2032-2024 | Class II | Streptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Areta Strep A Swab Test a | April 22, 2024 |